C.R. Bard, Inc.
Medical device manufacturer in Covington, GA.
655510(k) clearances
5PMA approvals
173recalls
Device types
- LJS Catheter, Intravascular, Therapeutic… 34
- FTL Mesh, Surgical, Polymeric 26
- LJT Port & Catheter, Implanted, Subcutaneous… 22
- FRN Pump, Infusion 22
- FGE Stents, Drains And Dilators For The Biliary… 16
- DYB Introducer, Catheter 16
- DQO Catheter, Intravascular, Diagnostic 16
- KNT Tubes, Gastrointestinal (And Accessories) 15
- DQY Catheter, Percutaneous 14
- DTK Filter, Intravascular, Cardiovascular 13
- LIT Catheter, Angioplasty, Peripheral… 13
- MSD Catheter, Hemodialysis, Implanted 12
- DRF Catheter, Electrode Recording, Or Probe… 11
- DQX Wire, Guide, Catheter 11
- KNW Instrument, Biopsy 11
- GDW Staple, Implantable 10
- EZL Catheter, Retention Type, Balloon 10
- DTN Reservoir, Blood, Cardiopulmonary Bypass 10
- KOD Catheter, Urological 10
- FOZ Catheter, Intravascular, Therapeutic… 9
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
| K213203 | Provena(TM) Midline CatheterPND · Special | 05/13/2022SE |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…DQY · Special | 05/04/2022SE |
| K212708 | Halo One Thin-Walled Guiding SheathDYB · Special | 09/23/2021SE |
| K211738 | Rotarex Atherectomy SystemMCW · Traditional | 09/14/2021SE |
| K203363 | Crosser iQ CTO Recanalization SystemPDU · Traditional | 08/12/2021SE |
| K203575 | GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional | 07/01/2021SESK |
| K201452 | Groshong NXT PICC CatheterLJS · Traditional | 03/12/2021SE |
| K203275 | Recon Support CatheterDQY · Traditional | 03/01/2021SE |
| K202150 | GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional | 11/18/2020SESK |
| K200818 | 3DMax MID Anatomical MeshFTL · Traditional | 07/17/2020SE |
| K200627 | GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional | 06/22/2020SESK |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional | 03/05/2020SESK |
| K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization DevicesKRD · Traditional | 02/04/2020SE |
| K192313 | Halo One Thin-Walled Guiding SheathDYB · Traditional | 12/19/2019SE |
| K192239 | WavelinQ Plus EndoAVF SystemPQK · Traditional | 10/17/2019SE |
| K191232 | AccuCath Ace Intravascular CatheterFOZ · Traditional | 09/18/2019SE |
| K191143 | PowerFlow Implantable Apheresis IV PortPTD · Traditional | 08/02/2019SE |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®)LJT · Traditional | 07/08/2019SE |
| K190185 | Phasix ST Mesh with Open Positioning SystemOWT · Traditional | 06/12/2019SE |
| K182796 | WavelinQ 4F EndoAVF SystemPQK · Traditional | 02/06/2019SE |
| K182008 | Phasix ST Mesh with Echo 2 Positioning SystemFTL · Traditional | 12/14/2018SE |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechIYO · Traditional | 10/24/2018SE |
| K180781 | Bard Vertus Foley CatheterEZL · Traditional | 09/19/2018SE |
| K181323 | Atlas Gold PTA Dilatation CatheterLIT · Traditional | 08/03/2018SE |
| K180560 | Sherlock 3CG+ T ip Confirmation SystemLJS · Traditional | 06/18/2018SE |
| K173143 | Phasix ST MeshOWT · Traditional | 04/25/2018SE |
| K172511 | Hickman TriFusion CatheterLJS · Traditional | 04/20/2018SE |
| K172932 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | 12/13/2017SE |
| K172397 | Sherlock 3CG Tip Positioning System StyletLJS · Special | 09/29/2017SE |
| K172571 | ULTRASCORE Focused Force PTA BalloonPNO · Special | 09/22/2017SE |
| K172247 | Magic3 Go Intermittent Urinary CatheterEZD · Traditional | 09/20/2017SE |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI · Special | 08/08/2017SE |
| K163216 | Pinpoint GT NeedlesBSP · Traditional | 06/27/2017SE |
| K163437 | hypodermic Pinpoint GT NeedlePVZ · Traditional | 06/23/2017SE |
| K170158 | PowerGlide ST Midline CatheterPND · Traditional | 06/01/2017SE |
| K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…GDW · Traditional | 05/31/2017SE |
| K171348 | Pinpoint GT Needle Guide KitsITX · Special | 05/22/2017SE |
| K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST…FTL · Traditional | 05/01/2017SE |
| K162441 | PowerPICC Provena Catheters with SOLO Valve TechnologyLJS · Traditional | 04/24/2017SE |
| K163001 | PowerFlow Apheresis I.V. PortPTD · Traditional | 04/17/2017SE |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fastenersGDW · Traditional | 04/11/2017SE |
| K163458 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | 04/04/2017SEKD |
| K162193 | XenMatrix AB Surgical GraftPIJ · Traditional | 12/23/2016SE |
| K162900 | PowerMidline CatheterPND · Special | 12/14/2016SE |
| K162894 | AccuCath Intravascular CatheterFOZ · Special | 11/15/2016SE |
| K162769 | Pinpoint GT Introducer NeedleDYB · Special | 11/04/2016SE |
| K162443 | PowerPICC Provena CathetersLJS · Special | 10/25/2016SE |
| K161424 | Phasix MeshOOD · Traditional | 09/29/2016SE |
| K162377 | PowerGlide Pro Midline CatheterFOZ · Special | 09/22/2016SE |
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetFPA · Traditional | 08/18/2016SE |
| K153393 | PowerMidline CatheterPND · Traditional | 06/28/2016SE |
| K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterLJS · Traditional | 06/14/2016SE |
| K161183 | Halo One Thin-Walled Guiding SheathDYB · Traditional | 06/03/2016SE |
| K153280 | PowerGlide Pro Midline CatheterFOZ · Traditional | 06/02/2016SE |
| K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure…GDW · Traditional | 05/31/2016SE |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted PortsLJT · Special | 05/20/2016SE |
| K153236 | Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with…FTL · Traditional | 05/13/2016SE |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian…DTK · Special | 04/29/2016SE |
| K160861 | Proxis Ureteral Access SheathFED · Traditional | 03/31/2016SE |
| K152136 | Recovery Cone Removal SystemMMX · Traditional | 02/18/2016SE |
| K152613 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | 01/19/2016SE |
| K153190 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | 01/05/2016SE |
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyIYO · Traditional | 12/14/2015SE |
| K153298 | AccuCath Intravascular CatheterFOZ · Special | 12/10/2015SE |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersLJT · Traditional | 11/20/2015SE |
| K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHFTL · Traditional | 09/18/2015SE |
| K151177 | XenMatrix AB Surgical GraftPIJ · Traditional | 07/30/2015SE |
| K150699 | Bard LubriGuard Foley CatheterEZL · Traditional | 07/28/2015SE |
| K150667 | True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional | 06/17/2015SE |
| K143380 | Phasix ST MeshOWT · Traditional | 06/05/2015SE |
| K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis CatheterNIE · Traditional | 06/01/2015SEKD |
| K150345 | Magic3 Go Intermittent Urinary CatheterEZD · Traditional | 05/11/2015SE |
| K142083 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | 04/17/2015SE |
| K142445 | Pinpoint GT Safety Introducer NeedleDYB · Traditional | 04/13/2015SE |
| K142818 | Phasix MeshOOD · Traditional | 03/31/2015SE |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemIYO · Special | 03/30/2015SE |
| K142706 | Modified ONFLEX MeshFTL · Traditional | 03/25/2015SE |
| K142711 | ONFLEX MeshFTL · Traditional | 03/20/2015SE |
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…GDW · Traditional | 03/12/2015SE |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation…GDW · Traditional | 03/09/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | 01/12/2015SE |
| K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain…DTK · Special | 12/09/2014SE |
| K142575 | Bard RiteCath Intermittent Urinary CatheterEZD · Traditional | 10/31/2014SE |
| K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyIYO · Traditional | 10/30/2014SE |
| K142267 | Sherlock 3CG Tip Positioning System StyletLJS · Traditional | 10/17/2014SE |
| K133456 | Power-Trialysis Short-Term Dialysis CatheterNIE · Traditional | 09/24/2014SEKD |
| K133223 | Xenmatrix AB Surgical GraftPIJ · Traditional | 09/19/2014SE |
| K141985 | True Ba V Balloon Valvuloplasty CatheterOZT · Traditional | 09/18/2014SE |
| K133251 | Bard Dignishield Stool Management SystemKNT · Traditional | 05/09/2014SESK |
| K140856 | Brachysource Seed Implants with Sourcecap Bioabsorbable CapsKXK · Special | 05/02/2014SE |
| K140501 | Xenmatrix Surgical GraftFTM · Special | 04/28/2014SE |
| K133470 | Bard Ritecath Intermittent CatheterEZD · Traditional | 04/04/2014SE |
| K140345 | The Sherlock 3CG Tip Confirmation System (TCS)LJS · Special | 03/14/2014SE |
| K133335 | Powerport Implantable PortLJT · Traditional | 02/14/2014SE |
| K133856 | Powerglide Midline CatheterFOZ · Special | 01/16/2014SE |
| K132441 | Bard Ventralex Hernia PatchFTL · Special | 12/13/2013SE |
| K132134 | Optifix Absorbable Fixation SystemGDW · Traditional | 12/02/2013SE |
| K132942 | Site-Rite Vision II Ultrasound SystemIYN · Special | 10/17/2013SE |
| K130792 | Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemFGE · Traditional | 08/30/2013SESU |
| K131493 | Sidekick and Usher Support CathetersDQY · Traditional | 08/02/2013SE |
| K131002 | Vida PTV Dilataton CatheterOMZ · Traditional | 07/02/2013SE |
| K130366 | Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitDTK · Traditional | 05/15/2013SE |
| K130786 | Sleek Otw Pta CatheterLIT · Special | 05/03/2013SE |
| K130968 | Ventralight ST Mesh with Echo PS Positioning SystemFTL · Special | 05/01/2013SE |
| K123718 | Permasorb Disposable Fixation DeviceGDW · Special | 01/22/2013SE |
| K123911 | Senomark Ultra Breast Tissue MarkerNEU · Special | 01/10/2013SE |
| K122899 | Powerport Clearvue Slim Implantable PortLJT · Traditional | 11/15/2012SE |
| K123179 | Ajust Helical Adjustable Single-Incision SlingPAH · Special | 11/02/2012SE |
| K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…FTL · Special | 11/02/2012SE |
| K122367 | Bard PTV Dilatation CatheterOMZ · Traditional | 11/02/2012SE |
| K122984 | Atlas Gold Pta Dilatation CatheterLIT · Traditional | 10/22/2012SE |
| K120728 | Phasix Plug and PatchOWT · Traditional | 10/22/2012SE |
| K120926 | Endobeam Holmium Laser FibersGEX · Traditional | 07/27/2012SE |
| K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial CoatingFTL · Traditional | 07/20/2012SE |
| K121856 | Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionLIT · Special | 07/11/2012SE |
| K121073 | Powerglide Midline CatheterFOZ · Traditional | 06/01/2012SE |
| K113808 | The Sherlock 3CG Tip Confirmation System (TCS)LJS · Traditional | 03/19/2012SE |
| K112791 | Sitescrub Ipa DeviceLKB · Traditional | 02/24/2012SE |
| K112497 | Meridian Filter System - Femoral Delivery KitDTK · Special | 10/24/2011SE |
| K112744 | Sapiens Tip Confirmation SystemLJS · Special | 10/20/2011SE |
| K112137 | Comfortglide Intermitent CatheterEZD · Traditional | 08/26/2011SESK |
| K102511 | Meridan Filter System- Jungular/Subeclavian Delivery KitDTK · Traditional | 08/24/2011SE |
| K112308 | Crosser Recanalization SystemPDU · Traditional | 08/17/2011SE |
| K102405 | Infusion Set for Powerpicc Solo 2 CatheterFPA · Traditional | 07/21/2011SE |
| K111850 | Vaccess Pta Dilatation CatheterDQY · Traditional | 07/13/2011SE |
| K111100 | Encor Enspire Breast Biopsy SystemKNW · Special | 06/16/2011SE |
| K111153 | Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation SystemGDW · Special | 05/24/2011SE |
| K110409 | Aspira Pleural Drainage SystemDWM · Special | 05/11/2011SE |
| K110396 | Aspira Peritoneal Drainage SystemPNG · Special | 05/06/2011SE |
| K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemFTL · Special | 04/01/2011SE |
| K101722 | Alyte Y-Mesh GraftOTO · Traditional | 04/01/2011SE |
| K101928 | Ventralex ST Hernia PatchFTL · Traditional | 03/23/2011SE |
| K101920 | Ventrio ST Hernia PatchFTL · Traditional | 03/23/2011SE |
| K103359 | Finesse Ultra Breast Biopsy System Driver (Blue, Pink)KNW · Special | 12/27/2010SE |
| K103109 | Ponsky* Non-Balloon Replacement Gastrostomy TubeKNT · Special | 12/22/2010SE |
| K102391 | Bard Dignishield Stool Management SystemKNT · Traditional | 12/22/2010SESK |
| K102766 | Composix L/P Mesh with Echo PS Positioning SystemFTL · Traditional | 12/16/2010SE |
| K103459 | Vascutrak Pta Dilatation CatheterPNO · Traditional | 12/13/2010SE |
| K102159 | Powerpicc SV CathetersLJS · Traditional | 11/17/2010SE |
| K101261 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | 07/29/2010SE |
| K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsDTK · Special | 06/25/2010SE |
| K093747 | Align and Align to Urethral Support SystemsOTN · Special | 05/07/2010SE |
| K100229 | Ventrio Hernia PatchFTL · Special | 04/21/2010SE |
| K093965 | Ultraverse 014 and 018 Balloon Dilatation CathetersLIT · Traditional | 03/17/2010SE |
| K093927 | 6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…LJS · Special | 02/04/2010SE |
| K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…DTK · Special | 01/14/2010SE |
| K093663 | Radionuclide Brachytherapy SourceKXK · Special | 12/23/2009SE |
| K092483 | Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018GDW · Traditional | 12/18/2009SE |
| K092607 | Ajust Adjustable Single Incision SlingPAH · Traditional | 11/20/2009SE |
| K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USKNW · Traditional | 11/10/2009SE |
| K090739 | Bard Sacrocolpopexy GraftOTO · Traditional | 11/10/2009SE |
| K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletLJS · Traditional | 08/07/2009SE |
| K091659 | Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732FTL · Traditional | 08/03/2009SE |
| K091370 | Radia Steerable Diagnostic CatheterDRF · Special | 06/05/2009SE |
| K090528 | Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…MSD · Traditional | 05/28/2009SESK |
| K090134 | Intravenous Power Injector Extension SetFPA · Traditional | 04/21/2009SE |
| K090512 | Powerport Duo M.R.I. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane…LJT · Special | 03/27/2009SE |
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterNIE · Traditional | 03/19/2009SE |
| K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017UNEU · Special | 03/18/2009SE |
| K090102 | Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersMPB · Special | 02/12/2009SEKD |
| K090101 | Equistream Long-Term Hemodialysis CathetersMSD · Special | 02/10/2009SESK |
| K083839 | Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemOTP · Special | 01/15/2009SE |
| K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…GDW · Traditional | 01/02/2009SE |
| K083657 | Conquest Pta Balloon Dilatation CatheterDQY · Traditional | 12/24/2008SE |
| K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsDTK · Special | 10/31/2008SE |
| K080944 | X-Force Nephrostomy Balloon Dilation CatheterLJE · Special | 10/23/2008SE |
| K082687 | Collamend FM ImplantFTM · Traditional | 10/17/2008SE |
| K082681 | Vacora Vacuum Assisted Biopsy SystemKNW · Special | 10/15/2008SE |
| K082571 | Avaulta Support SystemOTP · Special | 09/30/2008SE |
| K081777 | Ventrio Hernia PatchFTL · Traditional | 09/29/2008SE |
| K082306 | Powerloc Clear Safety Infusion SetFPA · Special | 08/28/2008SE |
| K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsDTK · Special | 07/30/2008SE |
| K081288 | Aspira Peritoneal Drainage SystemPNG · Traditional | 07/18/2008SE |
| K073598 | Bard Dignicare Stool Management SystemKNT · Traditional | 06/13/2008SESK |
| K081311 | Powerport Implanted Port with Groshong CatheterLJT · Special | 06/04/2008SE |
| K080170 | Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp)BTR · Special | 03/25/2008SE |
| K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…DTK · Traditional | 01/15/2008SE |
| K073472 | Vaccess Pta Balloon Dilatation CatheterLIT · Special | 01/09/2008SE |
| K073423 | MRI Powerport Implanted Port with 9.6 FR Silicone CatheterLJT · Special | 12/19/2007SE |
| K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing…EZL · Traditional | 12/07/2007SE |
| K070558 | Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley CathetersEZL · Traditional | 12/07/2007SE |
| K072549 | Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterLJT · Special | 11/14/2007SE |
| K071365 | Agento I.C. Silver-Coated Endotracheal TubeBTR · Traditional | 11/06/2007SE |
| K072215 | Titanium Powerport Isp Implanted PortLJT · Special | 11/01/2007SE |
| K072230 | Powerpicc SoloLJS · Traditional | 10/05/2007SE |
| K070201 | Bard Intra-Abdominal Pressure Monitoring Device, Model IAP-001PHU · Traditional | 08/01/2007SE |
| K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6IYO · Special | 05/18/2007SE |
| K070996 | 4 FR Single Lumen (SL) Powerpicc CatheterLJS · Special | 05/08/2007SE |
| K070879 | Bard Malecot and Pezzer DrainsFEW · Special | 04/24/2007SE |
| K063848 | Powergroshong Picc CatheterLJS · Traditional | 04/04/2007SE |
| K070073 | Align Urethral Support SystemOTN · Traditional | 03/21/2007SE |
| K063712 | Avaulta Support System/Avaulta Plus Biosynthetic Support SystemOTP · Traditional | 03/12/2007SE |
| K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FREZL · Traditional | 03/09/2007SE |
| K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeKNT · Traditional | 02/13/2007SE |
| K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterLJT · Traditional | 01/25/2007SE |
| K063632 | X-Force N30 Nephrostomy Balloon Dilation CatheterLJE · Special | 01/05/2007SE |
| K063446 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Special | 12/15/2006SE |
| K063240 | Sherlock TLS Stylet, Sherlock TLS DetectorLJS · Special | 11/21/2006SE |
| K063178 | Bard Collamend Implant, Models 1175102, 1175103, 1175104, 1175105, 1175106FTM · Traditional | 11/21/2006SE |
| K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138KNW · Special | 10/20/2006SE |
| K061179 | Powerhickman Long-Term Intravascular CatheterLJS · Traditional | 08/09/2006SE |
| K060812 | Powerport(Tm)Implanted Titanium Port W/8 Fr. Chronoflex Catheter-MultipleLJT · Traditional | 07/14/2006SE |
| K060636 | PALLADIUM-103 Seed Implant Kits -MultipleKXK · Traditional | 04/19/2006SE |
| K060341 | Sherlock Tip Location System (TLS)FOZ · Traditional | 04/14/2006SE |
| K052322 | Bard Collamend Implant, Models 1175101, 1175102, 1175103, 1175104, 1175105FTM · Traditional | 04/10/2006SE |
| K052155 | Bard Large Pore Soft Mesh and Soft Mesh PreshapedFTL · Traditional | 10/20/2005SE |
| K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineLJS · Traditional | 10/20/2005SE |
| K052517 | Site-Rite 5 Ultrasound SystemITX · Traditional | 09/29/2005SE |
| K050558 | Modification to: Recovery Filter System, Model RF-210FDTK · Traditional | 08/29/2005SESU |
| K051748 | Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersMSD · Special | 08/12/2005SE |
| K051316 | X-Force Nephrostomy Balloon Dilation CatheterLJE · Traditional | 07/18/2005SE |
| K051417 | 6 FR FL Powerhohn and Powerline CatheterLJS · Special | 06/30/2005SE |
| K050931 | 6 FR DL Powerpicc CatheterLJS · Special | 06/15/2005SE |
| K050006 | Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel…DRQ · Traditional | 05/27/2005SE |
| K050875 | U-Balloon Dilation CatheterEZN · Traditional | 05/26/2005SE |
| K050185 | Powerhohn and Powerline CathetersLJS · Traditional | 05/26/2005SE |
| K050724 | Sure-Point Midline Stepping and Stabilization SystemITX · Special | 04/18/2005SE |
| K050688 | Tegress Implant NeedleFBK · Special | 04/06/2005SE |
| K043246 | Brachysource Brachytherapy Seed ImplantsKXK · Traditional | 02/02/2005SE |
| K043502 | 6 FR Poly Per-Q-Cath Triple Lumen PiccLJS · Special | 01/14/2005SE |
| K043193 | Bard Inlayoptima Ureteral Stent with SutureFAD · Special | 12/07/2004SE |
| K042949 | Pelvilace Transobturator Biourethral Support System (Pelvilace to System)PAG · Traditional | 11/09/2004SE |
| K041088 | Trifusion, Model 0609190/0659350LJS · Abbreviated | 11/01/2004SE |
| K040658 | Bardex I.C. Latex Foley CatheterMJC · Traditional | 09/29/2004SE |
| K042026 | Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004FTL · Traditional | 09/10/2004SE |
| K042036 | Airguard Valved IntroducerDYB · Traditional | 08/23/2004SE |
| K041576 | SourcelinkKXK · Special | 07/02/2004SE |
| K041641 | Davol Delivery SystemGCJ · Traditional | 07/01/2004SE |
| K040504 | Bardex, Lubri-Sil and Lubri-Sil Ic All-Silicone Foley CathetersEZL · Traditional | 05/14/2004SE |
| K033389 | Powerpicc Catheters, Models 3175155, 3175135LJS · Traditional | 03/19/2004SE |
| K033814 | Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007FTL · Traditional | 03/01/2004SE |
| K040243 | Bard Atlas Pta Balloon Dilatation CatheterDQY · Special | 02/13/2004SE |
| K033719 | Bard Tigertail Ureteral CatheterKOD · Traditional | 02/04/2004SE |
| K033497 | Bard Luminexx 3 Biliary Stent and Delivery SystemFGE · Special | 02/04/2004SESU |
| K034020 | Groshong NXT Picc CathetersLJS · Special | 01/21/2004SE |
| K034019 | Poly Per-Q-Cath Picc CathetersLJS · Special | 01/21/2004SE |
| K034065 | Modification to X-Port Duo PortLJT · Special | 01/15/2004SE |
| K033936 | Bard Eliminator PET Balloon DilatorsKNQ · Special | 01/14/2004SE |
| K033778 | Modification to Bard Aquaguide Ureteral ConduitFED · Special | 12/30/2003SE |
| K033562 | Fastrac Gastric Access Port KitKNT · Special | 12/12/2003SE |
| K033294 | Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, KIT;16FR X 19 CM, Kit with…MSD · Special | 11/26/2003SESK |
| K032521 | Bard Dual Lumen Ureteral CatheterEYB · Traditional | 11/14/2003SE |
| K030792 | Bard Endotracheal Tube, CuffedBTR · Traditional | 11/14/2003SE |
| K033245 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Special | 11/06/2003SE |
| K030627 | Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110DRF · Traditional | 10/23/2003SE |
| K030277 | Soft-Cell Dual Lumen CathetersMSD · Abbreviated | 08/06/2003SE |
| K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersMPB · Abbreviated | 07/30/2003SE |
| K031328 | Recovery Filter System, Model RF-048FDTK · Abbreviated | 07/25/2003SE |
| K030442 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | 07/21/2003SE |
| K032044 | X-Prot Duo PortLJT · Special | 07/10/2003SE |
| K030020 | Hemosplit Long-Term Hemodialysis CatheterMSD · Abbreviated | 06/16/2003SE |
| K031000 | Labsystem III Ep Laboratory W/Windows Platform & Windows Ep Software Version 1.0DQK · Traditional | 06/03/2003SE |
| K031332 | Bard Pelvisoft Acellular Collagen BiomeshFTM · Abbreviated | 05/15/2003SE |
| K031295 | Bard Innerlace Biourethral Support SystemPAG · Traditional | 05/15/2003SE |
| K031186 | Luminexx Endoscopic Biliary StentFGE · Special | 05/06/2003SESU |
| K031129 | Poly Per-Q-Cath Picc Catheters; Poly RadpiccLJS · Special | 05/05/2003SE |
| K030438 | Bard Aquaguide Ureteral ConduitFED · Traditional | 03/17/2003SE |
| K024008 | Small Bard Ventralex PatchFTL · Traditional | 02/20/2003SE |
| K030255 | Silicone Dual Lumen Radpicc CathetersLJS · Special | 02/07/2003SE |
| K022447 | Bard Er Ureteral Stent with SutureFAD · Traditional | 01/23/2003SE |
| K021994 | Bard Conformexx Biliary Stent and Delivery SystemFGE · Abbreviated | 01/02/2003SESU |
| K023374 | Groshong NXT Dual Lumen Picc CathetersLJS · Abbreviated | 12/18/2002SE |
| K022236 | Recovery Filter System, Model RF-048FDTK · Special | 11/27/2002SE |
| K022983 | Bardport X-Port Isp PortLJT · Special | 09/25/2002SE |
| K002612 | Bardex I.C.Plus Foley Catheter with Silver Salts in Hydrogel Coating, Model 3CC Balloon:…EZL · Abbreviated | 09/03/2002SE |
| K022561 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | 08/23/2002SE |
| K022350 | Bard Crurasoft Patch, Models 0116003 & 0116001FTL · Traditional | 08/23/2002SE |
| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Traditional | 08/05/2002SE |
| K021736 | Bard Ventralex Hernia Patch, Models 0010302, 0010301FTL · Traditional | 07/16/2002SE |
| K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery SystemFGE · Special | 04/02/2002SESU |
| K014212 | Bard Conquest Pta Balloon Dilatation CatheterDQY · Special | 01/17/2002SE |
| K013598 | Reuse Claim for the Bard Electrophysiology Surelink, Templink, and Templink M Extension…DSA · Traditional | 01/11/2002SE |
| K013144 | Dual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard…KNT · Special | 10/19/2001SE |
| K012913 | Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterDQY · Special | 09/28/2001SE |
| K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen…LJS · Special | 09/10/2001SE |
| K011015 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | 06/22/2001SE |
| K010778 | Niagara Slim-CathMPB · Special | 04/13/2001SE |
| K010567 | Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless…MSD · Special | 03/28/2001SE |
| K010444 | Advantage Single-Use Electrosurgical Attachment-J-Hook Tip, L-Hook Tip, Corbitt Spatula…GEI · Traditional | 02/28/2001SE |
| K010169 | Bard Utraverse Small Vessel Pta Balloon Dilatation CatheterDQY · Special | 02/13/2001SE |
| K003186 | Bard Memotherm Endoscopic Biliary StentFGE · Traditional | 01/09/2001SESU |
| K003956 | Bard Endocinch Suturing System # 000452; 000454; 000595ODE · Traditional | 01/05/2001SE |
| K003793 | Bard Luminexx Biliary StentFGE · Special | 01/05/2001SESU |
| K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil…EZL · Abbreviated | 01/05/2001SE |
| K002868 | Bard All-Silicone 3-WAY Foley Catheter; Bard Lubri-Sil 3-WAY Foley Catheter; Bard…EZL · Abbreviated | 12/08/2000SE |
| K002684 | Composix E/X MeshFTL · Traditional | 10/11/2000SE |
| K002094 | Bard Memotherm Covered Esophageal Stent, Model MultipleESW · Traditional | 10/06/2000SE |
| K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model…LJS · Traditional | 09/19/2000SE |
| K994290 | Bard Endoscopic Suturing SystemODE · Traditional | 03/20/2000SE |
| K990504 | Memotherm Colorectal StentMQR · Traditional | 03/16/2000SE |
PMA approvals
- P170042 Covera Vascular Covered Stent · 07/30/2018 · 14 supplements
- P030030 Uryx Urethral Bulking Agent · 12/16/2004 · 4 supplements
- P920027 Albumin Coated Debakey(R) Vascular(R) Vascular-Ii · 10/21/1994 · 0 supplements
- P860064 Davol Long Term Epidural Catheter, Catheter with Vitacuff Antimicrobial Cuff and Repair Kit · 02/29/1988 · 9 supplements
- P800002 Avitene Microfibrillar Collagen Hemostat Non-Woven Web · 10/24/1980 · 32 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3119-2026 Class II | Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-3118-2026 Class II | Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-3117-2026 Class II | Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF:…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-3116-2026 Class II | Products that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter Tray…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-3115-2026 Class II | Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-3114-2026 Class II | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF:…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | 06/25/2026Open, Classified |
| Z-2226-2026 Class II | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422…Due to stain present on the surface of affected foley catheters. | 04/23/2026Open, Classified |
| Z-0908-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 11/06/2025Open, Classified |
| Z-0907-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 11/06/2025Open, Classified |
| Z-0906-2026 Class II | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 11/06/2025Open, Classified |
| Z-0905-2026 Class II | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 11/06/2025Open, Classified |
| Z-2591-2025 Class II | SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or… | 07/17/2025Open, Classified |
| Z-2590-2025 Class II | SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter…Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or… | 07/17/2025Open, Classified |
| Z-2589-2025 Class II | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter…Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or… | 07/17/2025Open, Classified |
| Z-2462-2025 Class II | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone…Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine… | 06/18/2025Open, Classified |
| Z-2076-2025 Class II | REF: 123400,Bard Urologist's Tray, For the Obstructed UrethraCather packaging may contain the incorrect French size. | 06/03/2025Open, Classified |
| Z-2075-2025 Class II | BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314…Cather packaging may contain the incorrect French size. | 06/03/2025Open, Classified |
| Z-2074-2025 Class II | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112…Cather packaging may contain the incorrect French size. | 06/03/2025Open, Classified |
| Z-1759-2025 Class I | Bard Single Intragastric Linton Balloon Tube, REF: 0092740Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | 04/17/2025Open, Classified |
| Z-1758-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | 04/17/2025Open, Classified |
| Z-1757-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | 04/17/2025Open, Classified |
| Z-1756-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | 04/17/2025Open, Classified |
| Z-1755-2025 Class I | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm…Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | 04/17/2025Open, Classified |
| Z-2154-2024 Class II | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical…Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures… | 05/09/2024Open, Classified |
| Z-0806-2024 Class II | Bard Suction Connector with ENFit, REF EN0066000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0805-2024 Class II | Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0804-2024 Class II | Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0803-2024 Class II | Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 14Fr., 48in…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0802-2024 Class II | Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0801-2024 Class II | Bard Lopez Valve with ENFit, REF EN0056000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0800-2024 Class II | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 18Fr., 48in Long…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0799-2024 Class II | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0798-2024 Class II | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 14Fr., 48in Long…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0797-2024 Class II | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit", 12Fr., 48in…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0796-2024 Class II | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long…BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0795-2024 Class II | Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0794-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0793-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0792-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0791-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0790-2024 Class II | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit… | 12/20/2023Open, Classified |
| Z-0554-2024 Class II | Sensica Urine Output System, Catalog Number SCCS1002BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet… | 11/15/2023Open, Classified |
| Z-1701-2023 Class II | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1700-2023 Class II | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GSome catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1699-2023 Class II | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1698-2023 Class II | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF…Some catheters had a manufacturing defect where the clear resealing label separating from the product foil… | 04/20/2023Open, Classified |
| Z-1293-2022 Class II | Sensica Urine Output SystemComplaints relating to urine output measurement accuracy. | 05/19/2022Open, Classified |
| Z-0667-2022 Class II | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16CThere is a potential to leak from the catheter where it connects to the drain bag | 01/27/2022Terminated |
| Z-0666-2022 Class II | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14CThere is a potential to leak from the catheter where it connects to the drain bag | 01/27/2022Terminated |
| Z-2541-2021 Class II | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock"…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2540-2021 Class II | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2539-2021 Class II | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2538-2021 Class II | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2537-2021 Class II | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2536-2021 Class II | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2535-2021 Class II | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine MeterThere is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2534-2021 Class II | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2533-2021 Class II | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2532-2021 Class II | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayThere is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2531-2021 Class II | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayThere is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2530-2021 Class II | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayThere is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2529-2021 Class II | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayThere is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2528-2021 Class II | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2527-2021 Class II | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2526-2021 Class II | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2525-2021 Class II | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2524-2021 Class II | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2523-2021 Class II | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2522-2021 Class II | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-2521-2021 Class II | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing…There is potential for packaging defects that may impact the sterile barrier. | 08/05/2021Open, Classified |
| Z-1431-2021 Class II | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) -…The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. | 01/11/2021Terminated |
| Z-1970-2020 Class II | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or…There is potential for a white paper-type residue attached to the catheter. | 04/15/2020Terminated |
| Z-1219-2020 Class II | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for…Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could… | 01/13/2020Terminated |
| Z-1357-2018 Class II | Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | 02/27/2018Terminated |
| Z-1356-2018 Class II | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | 02/27/2018Terminated |
| Z-1355-2018 Class II | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric…BMD has identified that the product code/lot number combination identified above may have ineffectively… | 02/27/2018Terminated |
| Z-1354-2018 Class II | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | 02/27/2018Terminated |
| Z-2064-2018 Class II | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx…Foley Catheter with Incorrect Retainer Cap Print | 12/13/2017Terminated |
| Z-2243-2018 Class II | CritiCore Automated Urine Output and Temperature MonitorIssues identified with the monitor including urine output measurement errors, temperature measurement errors… | 11/10/2017Open, Classified |
| Z-0565-2018 Class II | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine…BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output… | 11/10/2017Terminated |
| Z-0271-2018 Class II | Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains…Hydrogel peeling from the pads. | 10/16/2017Terminated |
| Z-0488-2018 Class II | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM)…The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the… | 09/29/2017Terminated |
| Z-1309-2018 Class II | Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | 09/14/2017Terminated |
| Z-1308-2018 Class II | Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | 09/14/2017Terminated |
| Z-1307-2018 Class II | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | 09/14/2017Terminated |
| Z-3226-2017 Class II | Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx…Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. | 07/28/2017Terminated |
| Z-2872-2017 Class II | BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and…Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's… | 06/02/2017Terminated |
| Z-0590-2018 Class III | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the… | 06/02/2017Open, Classified |
| Z-3042-2017 Class II | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V USPotential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is… | 03/31/2017Terminated |
| Z-1871-2017 Class II | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr.…Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex. | 03/09/2017Completed |
| Z-0267-2018 Class II | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in…Activity and quantity of seeds sent in shipments were incorrect. | 12/09/2016Terminated |
| Z-0406-2017 Class II | Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0405-2017 Class II | Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0404-2017 Class II | BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0403-2017 Class II | Bard Fluoro-4 Silicone Ureteral Stent, Bard Fluoro-4", Silicone Ureteral Coil Stent…Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the… | 10/13/2016Terminated |
| Z-0585-2017 Class II | C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx…Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. | 10/12/2016Terminated |
| Z-0363-2017 Class II | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8…Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. | 10/12/2016Terminated |
| Z-0600-2017 Class II | Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile…Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an… | 10/05/2016Terminated |
| Z-0738-2017 Class II | BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is available…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-0737-2017 Class II | BARD Piston Syringe, 60cc, Rx Only, Sterile, The BARD Syringe is available in a single…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-0736-2017 Class II | BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-0735-2017 Class II | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap…Package Defect: Products may be at risk for having a slit defect on the package and that may affect the… | 08/03/2016Terminated |
| Z-2831-2016 Class II | Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | 07/11/2016Terminated |
| Z-2830-2016 Class II | Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | 07/11/2016Terminated |
| Z-0967-2017 Class II | SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK…The product contained a latex catheter instead of a silicone catheter. | 07/11/2016Terminated |
| Z-2345-2016 Class III | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and…An internal review of an available product found that the Information For Use only contained English and… | 06/30/2016Terminated |
| Z-2333-2016 Class III | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization…Labeling problem | 06/29/2016Terminated |
| Z-1395-2016 Class II | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is…Complaints were received of restricted/inaccurate flow rate. | 03/04/2016Terminated |
| Z-0812-2016 Class III | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single…Report by a customer of an open package seal. | 01/04/2016Terminated |
| Z-1359-2016 Class II | BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended…Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 12/18/2015Terminated |
| Z-1358-2016 Class II | BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder…Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 12/18/2015Terminated |
| Z-1357-2016 Class II | BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary…Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 12/18/2015Terminated |
| Z-0760-2016 Class II | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient…Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was… | 11/10/2015Terminated |
| Z-1617-2016 Class II | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a…The product may contain electronic components that lead to a premature drainage of the internal control… | 11/09/2015Terminated |
| Z-0198-2016 Class III | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of…Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12… | 10/02/2015Terminated |
| Z-2732-2015 Class II | Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip…Potential breach of the sterile barrier packaging. | 08/24/2015Terminated |
| Z-2388-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2387-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2386-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2385-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2384-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-1358-2015 Class II | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok…Potential breach of the sterile barrier packaging. | 01/30/2015Terminated |
| Z-0163-2015 Class II | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a…The product is non-sterile. | 10/07/2014Terminated |
| Z-2021-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2020-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2019-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2018-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2017-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-1117-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1116-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1115-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1114-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1113-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1112-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1111-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1110-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1109-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1108-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1107-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1106-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1105-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1104-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1103-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1102-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1101-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1100-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1099-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1098-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1097-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1096-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-0438-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0437-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0436-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0435-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0434-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0433-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0432-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0431-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0430-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0429-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0428-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0427-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0426-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0425-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0424-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0423-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0422-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0421-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0420-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0419-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0418-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0417-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0416-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |