Bard Access Systems, Inc.
Medical device manufacturer in Salt Lake City, UT.
22510(k) clearances
0PMA approvals
77recalls
Device types
- LJT Port & Catheter, Implanted, Subcutaneous… 6
- LJS Catheter, Intravascular, Therapeutic… 6
- FOZ Catheter, Intravascular, Therapeutic… 2
- IYO System, Imaging, Pulsed Echo, Ultrasonic 2
- ITX Transducer, Ultrasonic, Diagnostic 1
- MSD Catheter, Hemodialysis, Implanted 1
- DWM Apparatus, Suction, Patient Care 1
- IYN System, Imaging, Pulsed Doppler, Ultrasonic 1
- MHC Needle, Interosseous 1
- PTI Non-Coring (Huber) Needle 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | 06/18/2025SE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle SetPTI · Traditional | 11/27/2024SE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | 10/31/2024SE |
| K240146 | BD Prevue II Peripheral Vascular Access SystemIYO · Special | 02/18/2024SE |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003)MHC · Special | 11/10/2022SE |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyLJS · Special | 08/24/2022SE |
| K210264 | BD PowerPiCC CatheterLJS · Traditional | 07/30/2021SE |
| K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideIYO · Traditional | 05/30/2012SE |
| K100402 | Site-Rite Vision Ultrasound SystemIYN · Traditional | 03/05/2010SE |
| K071095 | Aspira Pleural Drainage SystemDWM · Traditional | 05/18/2007SE |
| K053589 | Long-Term Hemodialysis Catheters with Biobloc CoatingMSD · Traditional | 04/13/2006SE |
| K053501 | PowerpiccLJS · Special | 01/13/2006SE |
| K051672 | PowerpiccLJS · Traditional | 11/23/2005SE |
| K050310 | Bardport Titanium PortsLJT · Special | 04/18/2005SE |
| K042445 | Site-Rite Needle Guide Kits and Probe Cover KitITX · Traditional | 10/19/2004SE |
| K971991 | Gesco Per-Q-Cath Midline CathetersFOZ · Traditional | 11/07/1997SE |
| K971990 | Gesco Per-Q-Cath Picc CathetersFOZ · Traditional | 11/07/1997SE |
| K935380 | Vascular Access Catheter AccessoriesLJS · Traditional | 02/17/1995SE |
| K926139 | Cathlink 20 Titanium Port W/Att. Polyurethane CathLJT · Traditional | 01/03/1995SE |
| K926331 | 3.0 FR Groshong Peripher Insert Cent Venous CathLJS · Traditional | 03/07/1994SEKD |
| K924250 | Plastic Low Profile Subcutaneous PortLJT · Traditional | 10/04/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2985-2026 | DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term…this is a downstream recall of class I recall RES 98777 | 08/10/2026Open, Classified |
| Z-2984-2026 | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis…this is a downstream recall of class I recall RES 98777 | 08/10/2026Open, Classified |
| Z-2872-2026 Class I | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to… | 07/30/2026Open, Classified |
| Z-2668-2026 Class II | 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2667-2026 Class II | CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2666-2026 Class II | 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2665-2026 Class II | 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2664-2026 Class II | CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2663-2026 Class II | CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2662-2026 Class II | CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2661-2026 Class II | 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2660-2026 Class II | 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2659-2026 Class II | 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2658-2026 Class II | CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2657-2026 Class II | 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code:…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2656-2026 Class II | CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-2655-2026 Class II | OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T…Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer… | 05/21/2026Open, Classified |
| Z-1507-2025 Class I | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483…Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded… | 03/11/2025Open, Classified |
| Z-1397-2022 Class I | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered…BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous… | 06/20/2022Open, Classified |
| Z-1994-2021 Class II | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label:…Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but… | 05/19/2021Terminated |
| Z-1991-2021 Class II | 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc…Catheter kits contained the incorrect micro-introducers. | 05/19/2021Terminated |
| Z-1669-2021 Class II | REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1668-2021 Class II | REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1667-2021 Class II | REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1666-2021 Class II | REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1665-2021 Class II | REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1664-2021 Class II | REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1663-2021 Class II | REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1662-2021 Class II | REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1661-2021 Class II | REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1660-2021 Class II | REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1659-2021 Class II | REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS)…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1658-2021 Class II | REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1657-2021 Class II | REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1656-2021 Class II | REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1655-2021 Class II | REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1654-2021 Class II | REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1653-2021 Class II | REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI:…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-1652-2021 Class II | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm…Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in… | 04/07/2021Terminated |
| Z-0536-2018 Class II | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a…Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension… | 12/28/2017Terminated |
| Z-2120-2017 Class II | StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile.…StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. | 04/25/2017Terminated |
| Z-0986-2017 Class II | SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as…Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection… | 12/19/2016Terminated |
| Z-0985-2017 Class II | MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75.…Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection… | 12/19/2016Terminated |
| Z-0982-2017 Class II | StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit…Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices… | 12/09/2016Terminated |
| Z-0981-2017 Class II | StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single…Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices… | 12/09/2016Terminated |
| Z-2808-2015 Class II | Marketing brochures for the PowerPICC and PowerPICC SOLO cathetersBard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to… | 07/20/2015Terminated |
| Z-2050-2015 Class III | PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen)…Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the… | 05/27/2015Terminated |
| Z-2049-2015 Class III | PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with…Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the… | 05/27/2015Terminated |
| Z-2048-2015 Class III | PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with…Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the… | 05/27/2015Terminated |
| Z-2047-2015 Class III | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with…Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the… | 05/27/2015Terminated |
| Z-1560-2015 Class II | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety…Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate… | 03/13/2015Terminated |
| Z-0493-2015 Class II | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard…Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were… | 11/03/2014Terminated |
| Z-1275-2015 Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong…Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact… | 08/08/2014Terminated |
| Z-1274-2015 Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits:…Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact… | 08/08/2014Terminated |
| Z-1273-2015 Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep…Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact… | 08/08/2014Terminated |
| Z-1272-2015 Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc…Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact… | 08/08/2014Terminated |
| Z-1271-2015 Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly…Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact… | 08/08/2014Terminated |
| Z-1443-2015 Class II | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing…Potential for inadvertent scalpel stick injury involving the safety scalpel. | 06/24/2014Terminated |
| Z-1300-2014 Class II | PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated…Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however… | 02/27/2014Terminated |
| Z-0815-2014 Class II | Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr…Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because… | 12/06/2013Terminated |
| Z-0814-2014 Class II | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code…Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because… | 12/06/2013Terminated |
| Z-1618-2013 Class II | StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only…BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to… | 06/10/2013Terminated |
| Z-0910-2013 Class II | Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with…Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual… | 02/21/2013Terminated |
| Z-0909-2013 Class II | Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with…Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual… | 02/21/2013Terminated |
| Z-2277-2012 Class III | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an…Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they… | 08/07/2012Terminated |
| Z-1133-2012 | BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen…The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port… | 02/16/2012Terminated |
| Z-3173-2011 | BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally…Implanted port has discrepant product information on package labeling. | 08/30/2011Terminated |
| Z-2782-2011 | Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for…Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the… | 06/21/2011Terminated |
| Z-2783-2011 | Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF…Kit label indicates the wrong dimension for an enclosed introducer. | 06/20/2011Terminated |
| Z-2962-2011 | Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-2961-2011 | Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-2960-2011 | Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-2959-2011 | Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | 05/21/2011Terminated |
| Z-0865-2011 | Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder…Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits. | 12/10/2010Terminated |
| Z-1525-2010 | PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex…8F PowerPort stems were mixed with 6F PowerPorts and packaged. | 03/18/2010Terminated |
| Z-0862-2010 | Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO…After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating… | 01/14/2010Terminated |
| Z-0861-2010 | Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF…After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating… | 01/14/2010Terminated |