Carefusion 2200 Inc
Medical device manufacturer in Vernon Hills, IL.
14510(k) clearances
0PMA approvals
114recalls
Device types
- KCT Sterilization Wrap Containers, Trays… 4
- OCV Endoscope Holder 2
- GCJ Laparoscope, General & Plastic Surgery 2
- GEI Electrosurgical, Cutting & Coagulation &… 2
- HES Insufflator, Carbon-Dioxide, Uterotubal… 1
- BTT Humidifier, Respiratory Gas, (Direct… 1
- DSA Cable, Transducer And Electrode, Patient… 1
- DXC Clamp, Vascular 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186DXC · Special | 03/04/2021SE |
| K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsGEI · Traditional | 05/04/2017SE |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire SystemDSA · Traditional | 01/18/2017SE |
| K160764 | AirLife Autofill Humidification ChamberBTT · Traditional | 08/25/2016SE |
| K153554 | Genesis Low Temperature Reusable Rigid Container SystemKCT · Traditional | 03/21/2016SE |
| K151036 | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsGCJ · Traditional | 02/01/2016SE |
| K142529 | Genesis Reusable Rigid Container SystemKCT · Traditional | 01/08/2015SE |
| K140850 | Genesis Reusable Rigid Container SystemKCT · Traditional | 08/27/2014SE |
| K140761 | Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian CannulaHES · Special | 04/21/2014SE |
| K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsGEI · Traditional | 09/07/2012SE |
| K112535 | Genesis Reusable Rigid Container SystemKCT · Traditional | 04/27/2012SE |
| K110257 | Diamond-Flex(R) GraspersGCJ · Traditional | 05/06/2011SE |
| K102179 | Enview (TM)OCV · Traditional | 12/02/2010SE |
| K093616 | V. Mueller Camera Controller with Storage CartOCV · Special | 12/23/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2429-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2428-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2427-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2426-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2425-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2424-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2423-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2422-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2421-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2420-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2419-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2418-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2417-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2416-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-2415-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | 07/13/2023Open, Classified |
| Z-1421-2023 Class II | (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1…A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch.… | 03/16/2023Open, Classified |
| Z-1236-2023 Class II | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and…Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis… | 01/30/2023Open, Classified |
| Z-0417-2023 Class II | CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0416-2023 Class II | CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0415-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0414-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0413-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0412-2023 Class II | CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0411-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0410-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0409-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0408-2023 Class II | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0407-2023 Class II | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0406-2023 Class II | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0405-2023 Class II | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0404-2023 Class II | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0403-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0402-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0401-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0400-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0399-2023 Class II | CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0398-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL…XXX | 11/02/2022Open, Classified |
| Z-0397-2023 Class II | CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0396-2023 Class II | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0395-2023 Class II | CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0394-2023 Class II | Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0393-2023 Class II | Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0392-2023 Class II | Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0391-2023 Class II | Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0390-2023 Class II | Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0389-2023 Class II | Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0388-2023 Class II | Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0387-2023 Class II | Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0386-2023 Class II | Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0385-2023 Class II | Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0384-2023 Class II | Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0383-2023 Class II | Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0382-2023 Class II | Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0381-2023 Class II | Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0380-2023 Class II | Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM)…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0379-2023 Class II | Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0378-2023 Class II | Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2"…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0377-2023 Class II | Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0376-2023 Class II | Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0375-2023 Class II | Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0374-2023 Class II | CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0373-2023 Class II | CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL…BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is… | 11/02/2022Open, Classified |
| Z-0219-2023 Class II | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0218-2023 Class II | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0217-2023 Class II | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0216-2023 Class II | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0215-2023 Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0214-2023 Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0213-2023 Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0212-2023 Class II | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0211-2023 Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0210-2023 Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0209-2023 Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0208-2023 Class II | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0207-2023 Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0206-2023 Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0205-2023 Class II | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0204-2023 Class II | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0203-2023 Class II | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM)…Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for… | 09/26/2022Open, Classified |
| Z-0833-2022 Class II | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5…The finished device package did not contain the IFU. | 02/23/2022Terminated |
| Z-2659-2020 Class II | Safe-T PLUS Thora-Para 5 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2658-2020 Class II | Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug FreeThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2657-2020 Class II | Thora-Para 5 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2656-2020 Class II | Safe-T PLUS Thora-Para 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2655-2020 Class II | Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug FreeThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2654-2020 Class II | Thora-Para 8 Fr Catheter Drainage Tray w/o LidocaineThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2653-2020 Class II | Thora-Para 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2652-2020 Class II | Safe-T-Centesis PLUS 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2651-2020 Class II | Safe-T-Centesis 8 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2650-2020 Class II | Safe-T-Centesis PLUS 6 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2649-2020 Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o LidocaineThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2648-2020 Class II | Safe-T-Centesis 6 Fr Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2647-2020 Class II | Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2646-2020 Class II | Thora-Para 5 Fr Non-Valved Catheter Drainage TrayThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the… | 05/28/2020Terminated |
| Z-2400-2020 Class II | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog… | 05/18/2020Terminated |
| Z-1426-2018 Class II | Thoracentesis/ Paracentesis Kit 10/CS; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1425-2018 Class II | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1424-2018 Class II | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6…The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1423-2018 Class II | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1422-2018 Class II | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM…The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-1421-2018 Class II | Manometer, 550 ml three-Way Stopcock; STERILE;The integrity of the sterile packaging is potentially compromised. | 02/23/2017Terminated |
| Z-2212-2016 Class I | DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s):…BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result… | 07/01/2016Terminated |
| Z-2847-2016 Class II | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches…The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the… | 06/29/2016Terminated |
| Z-2846-2016 Class II | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK…The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the… | 06/29/2016Terminated |
| Z-2689-2014 Class II | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing…The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk… | 07/31/2014Terminated |
| Z-2193-2013 Class II | *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500…Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing… | 08/28/2013Terminated |
| Z-1947-2013 Class II | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual…CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation… | 04/22/2013Terminated |
| Z-1901-2012 Class I | AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx…The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation… | 05/29/2012Terminated |
| Z-1900-2012 Class I | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx…The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation… | 05/29/2012Terminated |
| Z-1899-2012 Class I | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device…The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation… | 05/29/2012Terminated |
| Z-1209-2012 | Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone…The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also… | 02/07/2012Terminated |
| Z-1208-2012 | Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine…The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also… | 02/07/2012Terminated |
| Z-1207-2012 | Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle…The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also… | 02/07/2012Terminated |
| Z-2111-2010 | Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm)…The introducer needle is only 10 cm in length instead of the required 15 cm. | 06/25/2010Terminated |