Data / Medical devices / United States / Bard Access Systems, Inc.
Bard Access Systems, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 172 510(k) clearances
Bard Access Systems, Inc. is registered with the FDA (registration 3006260740) in Salt Lake City, UT, United States. It lists 50 device types. The FDA files 172 510(k) clearances under its listings, the newest dated September 5, 2025. 40 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006260740
- Address
- 605 North 5600 West, Salt Lake City, UT, United States, 84116
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- July 22, 1992
- Registered through
- 2026
- Brand names listed
- 9.5 Fr. DL Chronoflex Polyurethane, Accessory - Foam Strips, AccuCath Ace Intravascular Catheter, Advance Introducer and SecureLoc Safety Introducer, Align Introducers, AllPoints Dressing Change Kit, Alphacurve, BD Intraosseous Vascular Access System EMS Powered Driver (D001003) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 172.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2025 | K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | LJT | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| June 18, 2025 | K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | LJT | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| April 9, 2025 | K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | SEF | Substantially Equivalent | Becton Dickinson Inc. (Bd) | accessdata.fda.gov |
| November 27, 2024 | K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | PTI | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| October 31, 2024 | K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | LJT | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| July 29, 2024 | K240359 | PowerGlide Pro Midline Catheter | FOZ | Substantially Equivalent | Becton, Dickinson and Company (Bard Access Systems, Inc.) | accessdata.fda.gov |
| April 19, 2024 | K233106 | AccuCath Ace Intravascular Catheter | FOZ | Substantially Equivalent | Bard Access Systems, Inc. (C.R. Bard, Inc.) | accessdata.fda.gov |
| February 18, 2024 | K240146 | BD Prevue II Peripheral Vascular Access System | IYO | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| September 11, 2023 | K231283 | SiteRite 9 Ultrasound System | IYO | Substantially Equivalent | Bard Access Systems, Inc. (C.R. Bard, Inc.) | accessdata.fda.gov |
| November 10, 2022 | K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | MHC | Substantially Equivalent | Bard Access Systems | accessdata.fda.gov |
| August 24, 2022 | K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| May 13, 2022 | K213203 | Provena(TM) Midline Catheter | PND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 30, 2021 | K210264 | BD PowerPiCC Catheter | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| June 25, 2021 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | IYO | Substantially Equivalent | Bard Access Systems, Inc. (C.R. Bard, Inc.) | accessdata.fda.gov |
| March 12, 2021 | K201452 | Groshong NXT PICC Catheter | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 4, 2021 | K203193 | BD Intraosseous Infusion System | MHC | Substantially Equivalent | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | accessdata.fda.gov |
| April 7, 2020 | K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | FOZ | Substantially Equivalent | Bard Access Systems, Inc. (Bard Has Joined Bd) | accessdata.fda.gov |
| March 5, 2020 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters | MSD | Unknown | C. R. Bard | accessdata.fda.gov |
| November 13, 2019 | K191976 | Piper GO-IO Intraosseous Infusion System | FMI | Substantially Equivalent | Piper Access, LLC | accessdata.fda.gov |
| November 1, 2019 | K190855 | BD Acute Central Line | FOZ | Substantially Equivalent | Bard Access Systems, Inc. (Bard Has Joined Bd) | accessdata.fda.gov |
| September 18, 2019 | K191232 | AccuCath Ace Intravascular Catheter | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 2, 2019 | K191143 | PowerFlow Implantable Apheresis IV Port | PTD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 24, 2018 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | IYO | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| June 18, 2018 | K180560 | Sherlock 3CG+ T ip Confirmation System | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 26, 2018 | K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology | LJS | Substantially Equivalent | C.R. Bard, Inc (Bard Has Joined Bd) | accessdata.fda.gov |
| September 29, 2017 | K172397 | Sherlock 3CG Tip Positioning System Stylet | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 8, 2017 | K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | PTI | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 27, 2017 | K163216 | Pinpoint GT Needles | BSP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 23, 2017 | K163437 | hypodermic Pinpoint GT Needle | PVZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 1, 2017 | K170158 | PowerGlide ST Midline Catheter | PND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 22, 2017 | K171348 | Pinpoint GT Needle Guide Kits | ITX | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 17, 2017 | K163001 | PowerFlow Apheresis I.V. Port | PTD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 14, 2016 | K162900 | PowerMidline Catheter | PND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 15, 2016 | K162894 | AccuCath Intravascular Catheter | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 4, 2016 | K162769 | Pinpoint GT Introducer Needle | DYB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 25, 2016 | K162443 | PowerPICC Provena Catheters | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 22, 2016 | K162377 | PowerGlide Pro Midline Catheter | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 18, 2016 | K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | FPA | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 28, 2016 | K153393 | PowerMidline Catheter | PND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 14, 2016 | K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 14, 2015 | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | IYO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 20, 2015 | K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 1, 2015 | K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | NIE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| April 13, 2015 | K142445 | PINPOINT GT SAFETY INTRODUCER NEEDLE | DYB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 30, 2015 | K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | IYO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 27, 2015 | K141634 | NAUTILUS DELTA | LJS | Substantially Equivalent | Romedex International Srl | accessdata.fda.gov |
| October 17, 2014 | K142267 | Sherlock 3CG Tip Positioning System Stylet | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 24, 2014 | K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | NIE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| March 14, 2014 | K140345 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 16, 2014 | K133856 | POWERGLIDE MIDLINE CATHETER | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 17, 2013 | K132942 | SITE-RITE VISION II ULTRASOUND SYSTEM | IYN | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 3, 2013 | K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | LJS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| November 15, 2012 | K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 21, 2012 | K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | QSY | Substantially Equivalent | Hemcon Medical Technologies Europe, Ltd. | accessdata.fda.gov |
| May 30, 2012 | K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | IYO | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| March 19, 2012 | K113808 | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 1, 2012 | K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | FOS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| July 21, 2011 | K102405 | INFUSION SET FOR POWERPICC SOLO 2 CATHETER | FPA | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 22, 2010 | K103109 | PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE | KNT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 26, 2010 | K102548 | FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE | KNT | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| November 17, 2010 | K102159 | POWERPICC SV CATHETERS | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 29, 2010 | K101261 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | NFK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 5, 2010 | K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| February 24, 2010 | K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | DYB | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| February 4, 2010 | K093927 | 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 17, 2009 | K093252 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Substantially Equivalent | Footprint Medical, Inc. | accessdata.fda.gov |
| September 25, 2009 | K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | FOS | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| September 25, 2009 | K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | FOS | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| September 14, 2009 | K091488 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C | LJS | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| August 12, 2009 | K090576 | FOOTPRINT URINARY DRAINAGE CATHETER | EZD | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| August 7, 2009 | K091324 | SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 28, 2009 | K090528 | DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT | MSD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| May 4, 2009 | K090559 | FOOTPRINT MEDICAL SILICONE FEEDING TUBE | KNT | Substantially Equivalent | Footprint Medical | accessdata.fda.gov |
| April 21, 2009 | K090134 | INTRAVENOUS POWER INJECTOR EXTENSION SET | FPA | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 27, 2009 | K090512 | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 12, 2009 | K090102 | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS | MPB | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| February 10, 2009 | K090101 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS | MSD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| June 4, 2008 | K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 25, 2008 | K073050 | SAFESTEP MAX POWER-INJECTABLE INFUSION SET | FPA | Substantially Equivalent | Specialized Health Products International, Inc. | accessdata.fda.gov |
| December 19, 2007 | K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 14, 2007 | K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 1, 2007 | K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 31, 2007 | K072130 | PTFE PEEL AWAY MICROINTRODUCER | DYB | Substantially Equivalent | Intromed | accessdata.fda.gov |
| October 5, 2007 | K072230 | POWERPICC SOLO | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 30, 2007 | K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET | FPA | Substantially Equivalent | Pfm Medical, Inc. | accessdata.fda.gov |
| May 18, 2007 | K071204 | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 | IYO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 8, 2007 | K070996 | 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 4, 2007 | K063848 | POWERGROSHONG PICC CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 13, 2007 | K063118 | BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE | KNT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 25, 2007 | K063377 | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 15, 2006 | K063446 | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 | NFK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 5, 2006 | K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | NFK | Substantially Equivalent | Spire Biomedical, Inc. | accessdata.fda.gov |
| November 21, 2006 | K063240 | SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 9, 2006 | K061179 | POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 14, 2006 | K060812 | POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE | LJT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 2, 2006 | K061240 | SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES | LJS | Substantially Equivalent | Lucent Medical Systems | accessdata.fda.gov |
| April 14, 2006 | K060341 | SHERLOCK TIP LOCATION SYSTEM (TLS) | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 13, 2006 | K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | MSD | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| January 13, 2006 | K053501 | POWERPICC | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| November 23, 2005 | K051672 | POWERPICC | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2026 | 99534 | Class I | Ongoing | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialys | this is a downstream recall of class I recall RES 98777 | accessdata.fda.gov |
| July 30, 2026 | 99484 | Class I | Ongoing | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 4 | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placemen | accessdata.fda.gov |
| May 21, 2026 | 99096 | Class II | Ongoing | OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acut | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | accessdata.fda.gov |
| March 11, 2025 | 96426 | Class I | Ongoing | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 31941 | Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. | accessdata.fda.gov |
| June 20, 2022 | 90315 | Class I | Ongoing | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D0 | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable. | accessdata.fda.gov |
| May 19, 2021 | 88057 | Class II | Terminated | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire. | accessdata.fda.gov |
| May 19, 2021 | 88048 | Class II | Terminated | 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer | Catheter kits contained the incorrect micro-introducers. | accessdata.fda.gov |
| April 7, 2021 | 87594 | Class II | Terminated | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed. | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock | accessdata.fda.gov |
| December 28, 2017 | 79070 | Class II | Terminated | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. | Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction. | accessdata.fda.gov |
| April 25, 2017 | 77132 | Class II | Terminated | StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases contain | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. | accessdata.fda.gov |
| December 19, 2016 | 76008 | Class II | Terminated | MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton. Product Usage: Intended for th | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label. | accessdata.fda.gov |
| December 9, 2016 | 75908 | Class II | Terminated | StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). | accessdata.fda.gov |
| July 20, 2015 | 71757 | Class II | Terminated | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure. | accessdata.fda.gov |
| May 27, 2015 | 71420 | Class III | Terminated | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intrav | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. | accessdata.fda.gov |
| March 13, 2015 | 70834 | Class II | Terminated | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implan | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch. | accessdata.fda.gov |
| November 3, 2014 | 69683 | Class II | Terminated | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006. | Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically. | accessdata.fda.gov |
| August 8, 2014 | 70430 | Class II | Terminated | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Mid | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. | accessdata.fda.gov |
| June 24, 2014 | 70822 | Class II | Terminated | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels. | Potential for inadvertent scalpel stick injury involving the safety scalpel. | accessdata.fda.gov |
| February 27, 2014 | 67567 | Class II | Terminated | PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070 | Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs. | accessdata.fda.gov |
| December 6, 2013 | 66991 | Class II | Terminated | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goo | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. | accessdata.fda.gov |
| June 10, 2013 | 65202 | Class II | Terminated | StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters. | BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which | accessdata.fda.gov |
| February 21, 2013 | 64425 | Class II | Terminated | Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Ca | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. | accessdata.fda.gov |
| August 7, 2012 | 62780 | Class III | Terminated | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyur | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013. | accessdata.fda.gov |
| February 16, 2012 | 61185 | Not yet classified | Terminated | BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide re | The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit. | accessdata.fda.gov |
| August 30, 2011 | 59830 | Not yet classified | Terminated | BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system | Implanted port has discrepant product information on package labeling. | accessdata.fda.gov |
| June 21, 2011 | 57012 | Not yet classified | Terminated | Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. | Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number. | accessdata.fda.gov |
| June 20, 2011 | 59115 | Not yet classified | Terminated | Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. Product Usage: Designed f | Kit label indicates the wrong dimension for an enclosed introducer. | accessdata.fda.gov |
| May 21, 2011 | 59119 | Not yet classified | Terminated | Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access o | Labeling for drainage kit contained incomplete information. | accessdata.fda.gov |
| December 10, 2010 | 57457 | Not yet classified | Terminated | Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The Groshong is a family of single and dual -lumen peripherally plac | Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits. | accessdata.fda.gov |
| March 18, 2010 | 55175 | Not yet classified | Terminated | PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiri | 8F PowerPort stems were mixed with 6F PowerPorts and packaged. | accessdata.fda.gov |
| January 14, 2010 | 53341 | Not yet classified | Terminated | Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgica | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. | accessdata.fda.gov |
| January 20, 2009 | 52862 | Not yet classified | Terminated | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. | accessdata.fda.gov |
| December 22, 2008 | 50696 | Not yet classified | Terminated | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for perc | Out of specification replacement gastrostomy device was distributed. | accessdata.fda.gov |
| December 4, 2008 | 50678 | Not yet classified | Terminated | Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, STERILE. | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece. | accessdata.fda.gov |
| September 23, 2008 | 49523 | Not yet classified | Terminated | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. Dual Port Wizard Low Profile Replacement Gastrostomy Device is | Gastrostomy device anti-reflux valve may allow leakage from the stomach. | accessdata.fda.gov |
| August 10, 2007 | 38621 | Not yet classified | Terminated | Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116. | Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end. | accessdata.fda.gov |
| April 6, 2006 | 35140 | Not yet classified | Terminated | 18F Tri-Funnel Replacement Gastrostomy Tube | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carrie | accessdata.fda.gov |
| December 20, 2005 | 34518 | Not yet classified | Terminated | Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc. | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. | accessdata.fda.gov |
| November 3, 2004 | 30396 | Not yet classified | Terminated | Site-Rite Sterile Needle Guide Kit - 18 gauge | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. | accessdata.fda.gov |
| September 23, 2003 | 27431 | Not yet classified | Terminated | Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. | Sterility of product is compromised by open seals in packaging. | accessdata.fda.gov |
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Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.