Becton Dickinson & Co.
Medical device manufacturer in Franklin Lakes, NJ.
199510(k) clearances
0PMA approvals
439recalls
Device types
- LON System, Test, Automated, Antimicrobial… 107
- FMI Needle, Hypodermic, Single Lumen 10
- LSL Dna-Reagents, Neisseria 8
- JKA Tubes, Vials, Systems, Serum Separators… 8
- JTN Susceptibility Test Discs, Antimicrobial 7
- PSZ Devices Detecting Influenza A, B, And C… 6
- FMF Syringe, Piston 5
- MDB System, Blood Culturing 4
- MKZ Dna Probe, Nucleic Acid Amplification… 4
- NBW System, Test, Blood Glucose, Over The Counter 3
- GQG Antigen, Cf (Including Cf Controls)… 3
- LJS Catheter, Intravascular, Therapeutic… 3
- CGA Glucose Oxidase, Glucose 2
- HMY Keratome, Battery-Powered 2
- PHC Infusion Safety Management Software 2
- FPA Set, Administration, Intravascular 2
- FOZ Catheter, Intravascular, Therapeutic… 2
- NGT Saline, Vascular Access Flush 2
- JSO Culture Media, Antimicrobial Susceptibility… 2
- PER Automated Pipetting, Diluting And Specimen… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | 06/20/2025SE |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes…FMF · Special | 04/12/2017SE |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)LON · Traditional | 03/21/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | 08/08/2016SE |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory KitPSZ · Special | 02/25/2016SE |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 02/24/2016SE |
| K150059 | BD FlowSmart SetFPA · Traditional | 04/28/2015SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | 12/18/2014SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
| K140446 | BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA AssayMKZ · Traditional | 05/20/2014SE |
| K140591 | BD Phaseal Closed System Transfer Device - InjectorONB · Special | 05/14/2014SE |
| K133140 | BD Veritor System for the Rapid Detection of RSVGQG · Special | 11/15/2013SE |
| K133138 | BD Veritor System Flu A+B AssayPSZ · Special | 11/13/2013SE |
| K130268 | BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA AssayOUY · Traditional | 08/23/2013SE |
| K131301 | BD Facs Sample Prep Assistant IIIPER · Traditional | 08/02/2013SE |
| K131358 | BD Pen NeedleFMI · Traditional | 07/16/2013SE |
| K131331 | BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/Ml)LON · Traditional | 07/10/2013SE |
| K123404 | BD Phoenix Automated Microbiology System- Imipenem (0.0625-32 Ug/Ml)LON · Traditional | 06/27/2013SE |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)MDB · Traditional | 05/13/2013SE |
| K121655 | BD Alcohol SwabLKB · Traditional | 03/20/2013SE |
| K121050 | 0.9% Sodium Chloride Injection Usp BD Posiflush Flush Syringe, SF Flush SyringeNGT · Traditional | 02/07/2013SE |
| K123300 | BD Pen NeedleFMI · Special | 01/18/2013SE |
| K123213 | BD Phaseal Closed System Transfer DeviceONB · Traditional | 01/09/2013SE |
| K111860 | BD Max GBS Assay, BD Max InstrumentNJR · Traditional | 02/16/2012SE |
| K113241 | BD Emerald Single Use, Hypodermic SyringeFMF · Special | 11/28/2011SE |
| K110443 | BD Insyte Autoguard BCFOZ · Traditional | 07/19/2011SE |
| K103798 | BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA AssaysOQO · Traditional | 03/18/2011SE |
| K102064 | BD Facs Sample Prep Assistant III (SPA III)GKZ · Traditional | 03/07/2011SE |
| K092767 | BBL Chromagar Mrsa IIJSO · Traditional | 08/20/2010SE |
| K101514 | BD Directigen Ez RSVGQG · Traditional | 07/09/2010SE |
| K101502 | BD Vacutainer Rapid Serum Tube Blood Collection Tube, Model 368774JKA · Traditional | 06/29/2010SE |
| K101529 | BD Directigen Ez Flu A+B AssayPSZ · Special | 06/14/2010SE |
| K100209 | BD Eclipse Needle with Smartslip TechnologyFMI · Special | 02/19/2010SE |
| K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706JKA · Special | 01/21/2010SE |
| K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 11/13/2009SE |
| K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | 11/13/2009SE |
| K091377 | BD Flu+ SyringeFMF · Traditional | 07/02/2009SE |
| K091670 | BD L-Cath Single and Dual Lument Catheters, Midline CatheterLJS · Special | 07/01/2009SE |
| K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeNZW · Special | 06/10/2009SE |
| K090971 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 06/05/2009SE |
| K090824 | BD Probetec Chlamydia Trachomatis (CT) QX Amplified DNA AssayMKZ · Traditional | 06/02/2009SE |
| K090827 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/27/2009SE |
| K082852 | BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 Ug/MlLON · Traditional | 01/29/2009SE |
| K083572 | BD BACTEC Plus Aerobic/F Culture VialsMDB · Special | 12/24/2008SE |
| K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified DNA AssayLSL · Traditional | 12/11/2008SE |
| K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified DNA AssayMKZ · Traditional | 12/11/2008SE |
| K082913 | BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 Ug/MlLON · Traditional | 12/05/2008SE |
| K082538 | BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance TestLON · Traditional | 11/20/2008SE |
| K082271 | Fluconazole 25UG BBL Sensi-DiscJTN · Traditional | 10/06/2008SE |
| K082272 | Voriconazole 1UG BBL Sensi-DiscJTN · Traditional | 10/02/2008SE |
| K081446 | BD Spinal Needle, Models: 405081, 405235, 405236, 405237BSP · Abbreviated | 07/17/2008SE |
| K080998 | Doripenem 10UG BBL Sensi-DiscJTN · Traditional | 05/12/2008SE |
| K073589 | BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 Ug/Ml) Steptococcus…LON · Traditional | 03/05/2008SE |
| K073433 | BD Phoenix Automated Microbiology System-Piperacillin (GN) -128 Ug/MlLON · Traditional | 01/14/2008SE |
| K070691 | BBL Chromagar 0157JSI · Traditional | 11/20/2007SE |
| K070809 | BD Phoenix Automated Microbiology System-Minocycline (GP) 1-32 Ug/MlLON · Traditional | 09/24/2007SE |
| K071623 | BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN) 1/0.5-32/16 Ug/MlLON · Traditional | 08/20/2007SE |
| K070440 | BD Hypoint NeedleFMI · Special | 03/16/2007SE |
| K063689 | BD Directigen Ez Flu A+B TestPSZ · Traditional | 03/07/2007SE |
| K063486 | BD Phoenix Automated Microbiology System Minocycline (1-32 Ug/Ml) Gram Negative Id/Ast…LON · Traditional | 03/07/2007SE |
| K063824 | BD Phoenix Automated Microbiology System - Aztreonam (GN) 0.5-64UG/MLLON · Traditional | 02/14/2007SE |
| K063811 | BD Phoenix Automated Microbiology System - Cefazolin (GN) 0.5-32UG/MLLON · Traditional | 02/09/2007SE |
| K063300 | BD Phoenix Automated Microbiology System - Cefpodoxime (GN) 0.125-8UG/MLLON · Traditional | 01/29/2007SE |
| K063573 | BD Phoenix Automated Microbiology System-Ceftazidime (GN) 0.5-64 Ug/MlLON · Traditional | 01/11/2007SE |
| K063301 | BD Phoenix Automated Microbiology System - Cefepime (GN) 0.5-64UG/MLLON · Traditional | 12/08/2006SE |
| K062945 | BD Phoenix Automated Microbiology System - Ertapenem (GN) 0.25-32 Ug/MlLON · Traditional | 11/21/2006SE |
| K062944 | BD Phoenix Automated Microbiology System - Ceftriaxone (GN) 0.5-64UG/MLLON · Traditional | 11/15/2006SE |
| K062687 | BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (GN) 1/2 - 128/2UG/MLLON · Traditional | 10/24/2006SE |
| K062680 | BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 Ug/MlLON · Traditional | 10/05/2006SE |
| K062207 | BD Phoenix Automated Microbiology System - Cefuroxime (GN) 1-64 Ug/MlLON · Traditional | 09/13/2006SE |
| K062206 | BD Phoenix Automated Microbiology System - Moxifloxacin (Strep) 0.0625 - 8UG/MLLON · Traditional | 09/08/2006SE |
| K061869 | BD Phoenix Automated Microbiology System-Piperacillin-Tazobactam (GP) 1/4-128/4 Ug/MlLON · Traditional | 08/18/2006SE |
| K061867 | BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 Ug/MlLON · Traditional | 08/10/2006SE |
| K061673 | BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate(Gp) 0.25/0.12 -32/16…LON · Traditional | 07/28/2006SE |
| K061327 | BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16…LON · Traditional | 07/03/2006SE |
| K061355 | BD Phoenix Automated Microbiology System - Ampicillin (GN) 0.5-32 Ug/MlLON · Traditional | 06/07/2006SE |
| K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…LON · Traditional | 05/25/2006SE |
| K060558 | BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 Ug/MlLON · Traditional | 05/11/2006SE |
| K060447 | BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 Ug/Ml…LON · Traditional | 04/26/2006SE |
| K060257 | BD Phoenix Automated Microbiology System - Cefoxitin - 0.5-64 Ug/MlLON · Traditional | 04/14/2006SE |
| K060444 | BD Phoenix Automated Microbiology System - Cefepime (GN) , Ceftriaxone (GN), Cefotaxime…LON · Traditional | 04/12/2006SE |
| K060217 | BD Phoenix Automated Microbiology System - MOXIFLOXACIN-0.125-8 and CIPROFLOXACIN-0.25 -…LON · Traditional | 04/12/2006SE |
| K060493 | BD Phoenix Automated Microbiology System - Vancomycin-Gp Detection of Vrsa.LON · Traditional | 03/29/2006SE |
| K060007 | BD Autoshield Pen NeedleFMI · Traditional | 03/23/2006SE |
| K060218 | BD Phoenix Automated Microbiology System - ERYTHROMYCIN-0.0625-8 Ug/Ml, and…LON · Traditional | 03/17/2006SE |
| K060214 | BD Phoenix Automated Mircrobiology System Tetracycline-Gn 0.5-16 Ug/Ml and GP 0.5-16 Ug/MlLON · Traditional | 03/09/2006SE |
| K053241 | BD Phoenix Automated Microbiology System - Cefoxitin GP 1-32 G/MlLON · Traditional | 12/22/2005SE |
| K052481 | BD Viper SystemLSL · Special | 11/28/2005SE |
| K052853 | Tigecycline 15UG BBL Sensi-DiscJTN · Traditional | 11/17/2005SE |
| K052876 | Telithromycin 15UG BBL Sensi-DiscJTN · Traditional | 11/14/2005SE |
| K052270 | BD Phoenix Automated Microbiology System - Cefuroxime (Strep) 0.125 - 4UG/MLLON · Traditional | 10/05/2005SE |
| K052269 | BD Phoenix Automated Microbiology System -Ciprofloxacin GNLON · Traditional | 10/03/2005SE |
| K052250 | BD Phoenix Automated Microbiology System - Tobramycin (GP) 0.5-16UG/MLLON · Traditional | 09/30/2005SE |
| K051899 | BD Pen NeedleFMI · Traditional | 09/13/2005SE |
| K052224 | BD Probe Tec Urine Preservative TransportLSL · Special | 09/12/2005SE |
| K051689 | BD Phoenix Automated Microbiology System - Daptomycin 0.125 - 32 Ug/MlLON · Traditional | 08/05/2005SE |
| K051194 | BD Onecath Peripherally Inserted Central Catheter, Models 384647, 384667, 384687…LJS · Traditional | 07/25/2005SE |
| K051692 | BD Phoenix Automated Microbiology System - Amoxicillin (Strep) 0.0313 - 32 Ug/MlLON · Traditional | 07/14/2005SE |
| K051272 | BD Phoenix Automated Microbiology System - Clindamycin (Strep) 0.03125 -4 Ug/MlLON · Traditional | 07/11/2005SE |
| K042472 | BD Directigen Ez Flu a + BPSZ · Traditional | 07/07/2005SE |
| K051266 | BD Phoenix Automated Microbiology System - Linezolid (Strep) 0.25 - 16UG/MLLON · Traditional | 07/05/2005SE |
| K051204 | BD Phoenix Automated Microbiology System Cefepime (Strep) 0.0625-4UG/MLLON · Traditional | 06/24/2005SE |
| K051183 | BD Phoenix Automated Microbiology System - Gatifloxacin (Strep) 0.0625 -8UG/MLLON · Traditional | 06/21/2005SE |
| K051109 | BD Phoenix Automated Microbiology System - Erythromycin (Strep) 0.0156 - 4UG/MLLON · Traditional | 06/15/2005SE |
| K051138 | BD Phoenix Automated Microbiology System - Ceftriaxone (Strep) 0.0625 - 4UG/MLLON · Traditional | 06/03/2005SE |
| K050946 | BD Phoenix Automated Microbiology System-Meropenem (Strep) 0.03125-2 Ug/MlLON · Traditional | 05/27/2005SE |
| K050982 | BD Phonix Automated Microbiology System - Cefotaxime Strep (0.0625-4UG/ML)LON · Traditional | 05/24/2005SE |
| K050865 | BD Phoenix Automated Microbiology System-Trimethoprim-Sulfamethoxazole 0.0625/1.2-16/304…LON · Traditional | 05/20/2005SE |
| K050881 | BD Phoenix Automated Microbiology System - Tetracycline (Strep) 0.0625 - 16 Ug/MlLON · Traditional | 05/12/2005SE |
| K050780 | BD Phoenixtm Automated Microbiology System - Penicillin (Strep) 0.156 -32 Ug/MlLON · Traditional | 05/12/2005SE |
| K050747 | BD Phoenix Automated Microbiology System, Levofloxacin (Strep) 0.25-16 Ug/MlLON · Traditional | 04/29/2005SE |
| K050745 | BD Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/MlLON · Traditional | 04/29/2005SE |
| K050555 | BD Phoenix Automated Microbiology System - Cefazolin (GP) 2-32 Ug/MlLON · Traditional | 04/14/2005SE |
| K050400 | BD Phoenix Automated Microbiology System - Cephalothin (GP) 0.5-64 Ug/MlLON · Traditional | 03/22/2005SE |
| K043458 | BD Phoenix Automated Microbiology System - Cefotetan (GN) 2-64 Ug/MlLON · Traditional | 03/15/2005SE |
| K050089 | BD Phoenix Automated Microbiology System - Ampicillin-Sulbactam (GP) 2-32 Ug/MlLON · Traditional | 02/28/2005SE |
| K050191 | Modification to BD Facscanto System with BD Facscanto Clinical SoftwarePER · Special | 02/22/2005SE |
| K050062 | Gemifloxacin, 5UG BBL Sensi-DiscJTN · Traditional | 02/10/2005SE |
| K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/MLLON · Traditional | 01/21/2005SE |
| K043397 | Modification to BD Eclipse Hypodermic NeedleFMI · Special | 12/29/2004SE |
| K042932 | BD Phoenix Automated Microbiology System-Piperacillin-Tazobactam 0.5/4-128/4 Ug/MlLON · Traditional | 12/02/2004SE |
| K042812 | Bblchromagar MrsaJSO · Traditional | 11/22/2004SE |
| K042491 | BD Onecath Peripherally Inserted Central CatheterLJS · Traditional | 11/22/2004SE |
| K042934 | 1BD Soloshot Ix SyringeFMF · Special | 10/28/2004SE |
| K041478 | BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose MonitorCGA · Traditional | 10/28/2004SE |
| K042061 | 0.9% Sodium Chloride Injection, Usp BD Postflush SF Flush SyringeNGT · Special | 08/26/2004SE |
| K041384 | BD Phoenix Automated Microbiology System - Ceftazidime - Gram NegativeLON · Traditional | 08/03/2004SE |
| K033458 | BD Phoenix Automated Microbiology System - Confirmatory Esbl TestLON · Traditional | 05/28/2004SE |
| K040603 | Paradigm Link Blood Glucose MeterNBW · Traditional | 05/19/2004SE |
| K041071 | BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus…JKA · Special | 05/14/2004SE |
| K040716 | BD Phoenix Automated Microbiology System-Penicillin (GP) 0.0625-32 Ug/MlLON · Traditional | 05/14/2004SE |
| K033907 | BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5 -…LON · Traditional | 04/09/2004SE |
| K033362 | BD Phoenix Automated Microbiology System- Cefuroxime Gram NegativeLON · Traditional | 04/09/2004SE |
| K040099 | BD Phoenix Automated Microbiology SystemLON · Traditional | 03/19/2004SE |
| K040106 | BD Phoenix Automated Microbiology System -- Ampicillin -- Gram PositiveLON · Traditional | 03/11/2004SE |
| K033861 | BD Probetec Et Legionella Pneumophila (LP) Amplified DNA AssayLQH · Traditional | 03/09/2004SE |
| K032675 | BD Phoenix Automated Microbiology System-Cefepime (GN) 0.5-65 Ug/MlLON · Traditional | 03/01/2004SE |
| K040006 | BD Phoenix Automated Microbiology System-Linezolid-Gram PositiveLON · Traditional | 02/27/2004SE |
| K033889 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…LON · Traditional | 02/03/2004SE |
| K033784 | BD Phoenix Automated Microbiology System - Erythromycin 0.0625-8 Ug/MlLON · Traditional | 02/03/2004SE |
| K033500 | BD Careflow Central Venous CatheterFOZ · Traditional | 01/29/2004SE |
| K033560 | BD Phoenix Automated Microbiology System - Ceftazidime 0.5-64 Ug/Ml-Gram-Negative Id/Ast…LON · Traditional | 01/14/2004SE |
| K033557 | BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate-Gram NegativeLON · Traditional | 01/14/2004SE |
| K033558 | BD Phoenix Automated Microbiology System - Aztreonam 0.5-64 Ug/Ml-Gram-Negative Id/Ast…LON · Traditional | 12/19/2003SE |
| K033350 | BD Vacutainer Safety-Lok Administration Set with FilterFPA · Special | 11/18/2003SE |
| K032655 | BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 Ug/MlLON · Traditional | 10/06/2003SE |
| K032275 | BD Phoenix Automated Microbiology System-Imipenem 1-16 Ug/Ml Gram-Negative Id/Ast or Ast…LON · Traditional | 09/29/2003SE |
| K032299 | BD Phoenix Automated Microbiology System,-Ampicillin 0.5.-32 Ug/MlLON · Traditional | 09/22/2003SE |
| K032567 | BD Phoenix Automated Microbiology System-Cefoxitin-Gram NegativeLON · Traditional | 09/17/2003SE |
| K032528 | BD Eclipse Bifurcated NeedleSCL · Special | 09/09/2003SE |
| K031984 | BD Phoenix Automated Microbiology SYSTEM-TICARCILLIN-1-128 Ug/MlLON · Traditional | 08/27/2003SE |
| K032131 | BD Automated Microbiology System Tetracycline - GP 0.5-16 Ug/Ml-Gram Positive Id/Ast or…LON · Traditional | 08/18/2003SE |
| K031943 | BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 Ug/MlLON · Traditional | 08/06/2003SE |
| K031699 | BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole…LON · Traditional | 07/30/2003SE |
| K031912 | BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 Ug/MlLON · Traditional | 07/21/2003SE |
| K031679 | BD Phonenix Automated Microbiology SystemLON · Traditional | 07/16/2003SE |
| K031589 | BD Phoenix Automated Microbiology System-Nitrofurantoin Gram PositiveLON · Traditional | 07/11/2003SE |
| K031530 | BD Phoenix Automated Microbiology SYSTEM-NITROFURANTOIN-8-512 Ug/MlLON · Traditional | 07/10/2003SE |
| K031200 | Modification to BD Ultra-Fine III Pen NeedleFMI · Special | 06/24/2003SE |
| K023955 | BD Viper InstrumentJQW · Traditional | 06/24/2003SE |
| K031306 | BD Phoenix Automated Microbiology System - Moxifloxacin Gram PositiveLON · Traditional | 06/02/2003SE |
| K030986 | BD Phoenix Automated Microbiology System Trimethoprim - GN 0.5-16 Ug/MlLON · Traditional | 05/16/2003SE |
| K030677 | BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveLON · Traditional | 04/01/2003SE |
| K030579 | BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 Ug/MlLON · Traditional | 03/21/2003SE |
| K024153 | BD Phoenix Automated Microbiology System - Tetracycline - 0.5-16 Ug/MlLON · Traditional | 02/10/2003SE |
| K024152 | BD Phoenix Automated Microbiology System - Rifampin 0.25-32 Ug/MlLON · Traditional | 01/31/2003SE |
| K023568 | BD Phoenix Automated Microbiology SystemLON · Traditional | 01/24/2003SE |
| K024112 | BD Insulin SyringeFMF · Special | 01/09/2003SE |
| K023895 | BD Phoenix Automated Microbiology System - Ciprofloxacin GNLON · Traditional | 01/08/2003SE |
| K024109 | BD Ultra-Fine III Pen NeedleFMI · Special | 12/30/2002SE |
| K023634 | BD Phoenix Automated Microbiology System-Gentamicin GN (0.25-16UG/ML)LON · Traditional | 12/24/2002SE |
| K023527 | BD Phoenix Automated Microbiology System - Norfloxacin - 0.25-16 Ug/MlLON · Traditional | 12/23/2002SE |
| K023858 | BD Phoenix Automated Microbiology SystemLON · Traditional | 12/20/2002SE |
| K022133 | BD Directigen Ez RSV KitGQG · Traditional | 12/10/2002SE |
| K023219 | Becton Dickinson Diabetes SoftwareNBW · Traditional | 12/06/2002SE |
| K023331 | BD Vacutainer SST II Plus TubesJKA · Traditional | 11/25/2002SE |
| K023444 | BD Phoenix Automated Microbiology SYSTEM-AMIKACIN-0.5-64 Ug/MlLON · Traditional | 11/12/2002SE |
| K023301 | BD Phoenix Automated Microbiology SystemLON · Traditional | 11/12/2002SE |
| K023273 | BD Phoenix Automated Microbiology System - Gentamicin 0.25 - 16 Ug/MlLON · Traditional | 10/31/2002SE |
| K023092 | BD K-4000 Microkeratome SystemHMY · Special | 10/18/2002SE |
| K022637 | BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional | 10/16/2002SE |
| K022581 | Becton Dickinson Logic Blood Glucose Monitoring SystemNBW · Traditional | 10/09/2002SE |
| K022580 | Bacton Dickinson Latitude Blood Glucose Monitoring SystemCGA · Traditional | 10/09/2002SE |
| K022875 | Modification to BD Vacutainer Push Button Blood Collection SetJKA · Special | 09/11/2002SE |
| K022172 | BD Phoenix Automated Microbiology SystemLON · Traditional | 08/12/2002SE |
| K022426 | BD Preset Blood Collection Syringe, BD A-Line Blood Collection Syringe, Models 365313…JKA · Special | 08/08/2002SE |
| K021954 | BD Phoenix Automated Microbiology System-Clindamycin 0.125-8.0MCG/MLLON · Traditional | 08/01/2002SE |
| K022130 | BD Vacutainer Plus PST II TubeJKA · Traditional | 07/29/2002SE |
| K022129 | BD Phoenix Automated Microbiology System Moxifloxacin 0.125-8 Ug/MlLON · Traditional | 07/25/2002SE |
| K021582 | Bactec Mgit 960 Pza KitMJA · Traditional | 07/13/2002SE |
| K020321 | BD Phoenix Automated Microbiology SystemLON · Traditional | 05/23/2002SE |
| K020842 | Ertapenem 10UG BBL Sensi-DiscJTN · Traditional | 05/15/2002SE |
| K014123 | Bactec Mgit 960 Sire KitsMJA · Traditional | 04/19/2002SE |
| K020323 | BD Phoenix Automated Microbiology SystemLON · Traditional | 04/04/2002SE |
| K020322 | BD Phoenix Automated Microbiology SystemLON · Traditional | 03/27/2002SE |
| K013971 | BD Vacutainer Safety Coagulation TubeJKA · Traditional | 02/01/2002SE |
| K012351 | Bdprobetec Et Ct/Gc Amplified DNA AssayLSL · Traditional | 09/18/2001SE |
| K011984 | BD Vacutainer Push Button Blood Colection SetFMI · Traditional | 08/29/2001SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2257-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2256-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2255-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2254-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2253-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2252-2026 Class I | BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2251-2026 Class I | BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2250-2026 Class I | BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2249-2026 Class I | BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-2248-2026 Class I | BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | 04/27/2026Open, Classified |
| Z-1983-2026 Class II | BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating… | 04/07/2026Open, Classified |
| Z-1982-2026 Class II | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating… | 04/07/2026Open, Classified |
| Z-1496-2026 Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk…During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated… | 01/27/2026Open, Classified |
| Z-0484-2026 Class II | BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly… | 10/23/2025Open, Classified |
| Z-0504-2026 Class II | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. | 10/14/2025Open, Classified |
| Z-0240-2026 Class II | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number:…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0239-2026 Class II | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0238-2026 Class II | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0237-2026 Class II | BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0236-2026 Class II | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-0235-2026 Class II | BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer…Product service credentials used by some BD technical support teams to access certain BD products were… | 09/23/2025Open, Classified |
| Z-2162-2025 Class II | BD COR System Software. Model Number: 444829.Potential for functionality issue that supports the Over labeling feature and could lead to possible false… | 06/23/2025Open, Classified |
| Z-2023-2025 Class II | BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of…BD has received additional complaints of intermittent false resistance results for PZA during susceptibility… | 05/20/2025Open, Classified |
| Z-1296-2025 Class II | BD BBL TB Stain Kit K, Catalog (REF): 212522One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis… | 02/12/2025Open, Classified |
| Z-1004-2025 Class II | BD PCR Cartridges used with MAX System. Model Number: 437519Potential for signal drift in specific lots of BD PCR Cartridges. | 12/19/2024Open, Classified |
| Z-0621-2025 Class II | BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g…BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to… | 11/06/2024Open, Classified |
| Z-0596-2025 Class II | BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0595-2025 Class II | BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0594-2025 Class II | BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0593-2025 Class II | BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0592-2025 Class II | BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number:…BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0591-2025 Class II | BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog…BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0590-2025 Class II | BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0589-2025 Class II | BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0588-2025 Class II | BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0587-2025 Class II | BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0586-2025 Class II | BD EpiCenter Data Management System, Multi User Software Version or Model: 440981…BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0585-2025 Class II | BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0584-2025 Class II | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | 10/31/2024Open, Classified |
| Z-0026-2025 Class II | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and…Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an… | 09/12/2024Open, Classified |
| Z-3247-2024 Class II | BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial…Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50… | 08/01/2024Open, Classified |
| Z-3246-2024 Class II | BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial…Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50… | 08/01/2024Open, Classified |
| Z-2686-2024 Class II | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of…May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of… | 07/18/2024Open, Classified |
| Z-2585-2024 Class II | BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution…There is a potential risk that the image colony count does not adequately reflect the actual plate colony… | 07/09/2024Open, Classified |
| Z-2023-2024 Class II | BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal…Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. | 05/07/2024Open, Classified |
| Z-1399-2024 Class II | BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated…Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast… | 02/29/2024Open, Classified |
| Z-1398-2024 Class II | BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated…Products were found to have confirmed drug cross contamination prior to release may lead to incorrect… | 02/29/2024Open, Classified |
| Z-1040-2024 Class II | BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1039-2024 Class II | BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1038-2024 Class II | BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1037-2024 Class II | BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1036-2024 Class II | BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1035-2024 Class II | BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1034-2024 Class II | BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1033-2024 Class II | BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1032-2024 Class II | BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1031-2024 Class II | BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1030-2024 Class II | BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1029-2024 Class II | BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1028-2024 Class II | BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1027-2024 Class II | BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1026-2024 Class II | BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1025-2024 Class II | BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1024-2024 Class II | BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1023-2024 Class II | BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1022-2024 Class II | BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1021-2024 Class II | BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1020-2024 Class II | BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1019-2024 Class II | BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1018-2024 Class II | BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1017-2024 Class II | BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1016-2024 Class II | BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1015-2024 Class II | BD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1014-2024 Class II | BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1013-2024 Class II | BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 g, Catalog Number 231660. Used for…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1012-2024 Class II | BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No.…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-1011-2024 Class II | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629.…There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing… | 01/08/2024Open, Classified |
| Z-0736-2024 Class II | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with…An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General… | 11/16/2023Open, Classified |
| Z-0351-2024 Class II | BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined…Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | 10/11/2023Open, Classified |
| Z-0350-2024 Class II | BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS…Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | 10/11/2023Open, Classified |
| Z-0349-2024 Class II | BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set…Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | 10/11/2023Open, Classified |
| Z-0110-2024 Class II | BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode… | 09/12/2023Open, Classified |
| Z-2099-2023 Class II | BD Synapsys Informatics Solution, Catalog Number 444150There is a risk of mis-association of patient demographic data for users who choose to report results… | 06/08/2023Open, Classified |
| Z-1682-2023 Class II | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test…IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the… | 05/01/2023Open, Classified |
| Z-1415-2023 Class II | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as…Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform… | 03/22/2023Open, Classified |
| Z-1244-2023 Class II | BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1243-2023 Class II | BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1242-2023 Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1241-2023 Class II | BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1240-2023 Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1239-2023 Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale-…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1238-2023 Class II | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1237-2023 Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-0473-2023 Class II | BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species.…Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of… | 11/21/2022Open, Classified |
| Z-0232-2023 Class II | BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification…Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when… | 10/13/2022Open, Classified |
| Z-0095-2023 Class II | BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number…The affected product contains isobutylene which has recently demonstrated potential interference in… | 09/15/2022Open, Classified |
| Z-1555-2022 Class II | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer…Incorrect expiration date listed on the product labels. The expiration date listed on the product label is… | 07/18/2022Open, Classified |
| Z-1441-2022 Class II | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1440-2022 Class II | Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1439-2022 Class II | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1438-2022 Class II | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1437-2022 Class II | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1436-2022 Class II | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1435-2022 Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1434-2022 Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1433-2022 Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1432-2022 Class II | BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1431-2022 Class II | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton)…May have the potential for leakage at the housing component of the stopcock, may result in delay or… | 05/09/2022Open, Classified |
| Z-1018-2022 Class II | BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version…When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the… | 03/09/2022Terminated |
| Z-0665-2022 Class III | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed…May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when… | 01/06/2022Open, Classified |
| Z-0630-2022 Class II | BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient…May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative… | 01/05/2022Open, Classified |
| Z-0179-2022 Class II | BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal…Holes in product packaging impacts package integrity and may compromise sterility. | 09/27/2021Terminated |
| Z-1416-2021 Class II | BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative…BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing… | 03/24/2021Terminated |
| Z-1378-2021 Class II | BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic…Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected… | 03/17/2021Terminated |
| Z-1377-2021 Class II | BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic…Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected… | 03/17/2021Terminated |
| Z-0954-2021 Class II | BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro…Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System… | 01/07/2021Terminated |
| Z-1109-2021 Class II | BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts… | 12/23/2020Terminated |
| Z-0924-2021 Class II | BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of…BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated… | 12/09/2020Terminated |
| Z-0923-2021 Class II | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of…BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated… | 12/09/2020Terminated |
| Z-0766-2021 Class II | BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0765-2021 Class II | BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0764-2021 Class II | BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0763-2021 Class II | BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0762-2021 Class II | BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0761-2021 Class II | BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0760-2021 Class II | BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0759-2021 Class II | BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of…BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could… | 12/08/2020Terminated |
| Z-0588-2021 Class II | BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for…BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No.… | 11/18/2020Terminated |
| Z-0508-2021 Class II | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a…Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the… | 10/23/2020Terminated |
| Z-0295-2021 Class II | Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral…Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a… | 09/14/2020Terminated |
| Z-0294-2021 Class II | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral…Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a… | 09/14/2020Terminated |
| Z-0125-2021 Class II | BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538…Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in… | 09/14/2020Terminated |
| Z-2889-2020 Class II | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in packPrinted scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed… | 07/28/2020Terminated |
| Z-2754-2020 Class II | BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI…BD is experiencing elevated rates of potential false positive results from certain customers when using the… | 07/20/2020Terminated |
| Z-2671-2020 Class II | SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2670-2020 Class II | PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2669-2020 Class II | SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2668-2020 Class II | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2667-2020 Class II | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2666-2020 Class II | SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482)…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2665-2020 Class II | SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2664-2020 Class II | SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2663-2020 Class II | PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2662-2020 Class II | PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2661-2020 Class II | PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2660-2020 Class II | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers…Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that… | 06/19/2020Terminated |
| Z-2065-2020 Class II | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and… | 04/16/2020Terminated |
| Z-2048-2020 Class II | BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | 04/14/2020Terminated |
| Z-2047-2020 Class II | BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | 04/14/2020Terminated |
| Z-2046-2020 Class II | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms…May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci… | 04/14/2020Terminated |
| Z-1795-2020 Class II | CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx…The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. | 03/26/2020Terminated |
| Z-1946-2020 Class II | PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number:…Iincorrectly packaged without the required lidocaine as labeled | 03/17/2020Terminated |
| Z-2082-2020 Class II | BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435The kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2081-2020 Class II | BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418BThe kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2080-2020 Class II | BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417BThe kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2079-2020 Class II | BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278The kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2078-2020 Class II | BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277The kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2077-2020 Class II | BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276The kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2076-2020 Class II | BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026AThe kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-2075-2020 Class II | BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025The kits contain surgical gowns which were subject to a recall by the supplier. | 02/26/2020Terminated |
| Z-0518-2020 Class II | Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human…The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8… | 11/04/2019Terminated |
| Z-0500-2020 Class II | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with… | 10/14/2019Terminated |
| Z-0499-2020 Class II | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with… | 10/14/2019Terminated |
| Z-0285-2020 Class II | 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023…A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. | 09/16/2019Terminated |
| Z-2411-2019 Class II | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number:…Product Pouches may not be sealed properly and compromise the sterility of the device | 08/01/2019Terminated |
| Z-0193-2020 Class II | BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number…Separation of front and rear barrels upon activation of the safety feature that retracts the needle | 07/31/2019Terminated |
| Z-2439-2019 Class II | BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog…An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch… | 07/26/2019Terminated |
| Z-2438-2019 Class II | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog…An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch… | 07/26/2019Terminated |
| Z-2339-2019 Class II | Kit BD Max Enteric Viral Panel EU Catalog # 443985The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2338-2019 Class II | Kit EXT Enteric Bacterial Panel; Catalog # 443812The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2337-2019 Class II | Kit BD Max Enteric Viral Panel RUO; Catalog # 443715The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2336-2019 Class II | Kit BD Max Vaginal Panel; Catalog # 443712The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2335-2019 Class II | Kit BD Max GC RT PCR Assay; Catalog # 443486The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2334-2019 Class II | Kit BD Max MRSA XT; Catalog # 443461The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2333-2019 Class II | Kit BD Max StaphSR; Catalog # 443419The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2332-2019 Class II | Kit BD Max StaphSR; Catalog # 443418The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2331-2019 Class II | Kit BD Max CT/GC/TV; Catalog # 442970The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2330-2019 Class II | Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2329-2019 Class II | Kit BD Max Enteric Parasite Panel EU; Catalog # 442960The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2328-2019 Class II | Kit BD Max MRSA; Catalog # 442953The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2327-2019 Class II | Kit BD Max ExK TNA 2; Catalog # 442825The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2326-2019 Class II | Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2325-2019 Class II | Kit BD Max ExK DNA 2 USA; Catalog # 442819The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2324-2019 Class II | Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2323-2019 Class II | Kit BD Max ExK DNA 1 USA; Catalog # 442817The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2322-2019 Class II | Kit BD Max Cdiff EU; Catalog # 442555The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2321-2019 Class II | Kit BD Max Check-Points CPO IVD EU; Catalog # 278102The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | 07/17/2019Terminated |
| Z-2310-2019 Class II | BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2309-2019 Class II | BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2308-2019 Class II | BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2307-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2306-2019 Class II | BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2305-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2304-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2303-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2302-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2301-2019 Class II | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2300-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2299-2019 Class II | BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |
| Z-2298-2019 Class II | BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number…False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples… | 06/12/2019Terminated |