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Bard Access Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
48 (2 Class I)
510(k) Clearances
22
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1507-2025Class IBD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 317435March 11, 2025
Z-1397-2022Class IIntraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver June 20, 2022
Z-1991-2021Class II5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc PolyuretMay 19, 2021
Z-1994-2021Class II5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICCMay 19, 2021
Z-1666-2021Class IIREF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full KiApril 7, 2021
Z-1653-2021Class IIREF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)108017412April 7, 2021
Z-1663-2021Class IIREF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic KiApril 7, 2021
Z-1661-2021Class IIREF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full KitApril 7, 2021
Z-1657-2021Class IIREF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)108017412April 7, 2021
Z-1662-2021Class IIREF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, MaximalApril 7, 2021
Z-1669-2021Class IIREF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035April 7, 2021
Z-1667-2021Class IIREF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, April 7, 2021
Z-1665-2021Class IIREF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet TApril 7, 2021
Z-1655-2021Class IIREF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01April 7, 2021
Z-1668-2021Class IIREF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086April 7, 2021
Z-1652-2021Class IIREF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)108April 7, 2021
Z-1664-2021Class IIREF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic KApril 7, 2021
Z-1656-2021Class IIREF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)1080174103April 7, 2021
Z-1659-2021Class IIREF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic KiApril 7, 2021
Z-1654-2021Class IIREF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035April 7, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable September 5, 2025
K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable PJune 18, 2025
K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetNovember 27, 2024
K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsOctober 31, 2024
K240146BD Prevue™ II Peripheral Vascular Access SystemFebruary 18, 2024
K223198BD Intraosseous Vascular Access System EMS Powered Driver (D001003)November 10, 2022
K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyAugust 24, 2022
K210264BD PowerPiCC CatheterJuly 30, 2021
K120882SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDEMay 30, 2012
K100402SITE-RITE VISION ULTRASOUND SYSTEMMarch 5, 2010
K071095ASPIRA PLEURAL DRAINAGE SYSTEMMay 18, 2007
K053589LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATINGApril 13, 2006
K053501POWERPICCJanuary 13, 2006
K051672POWERPICCNovember 23, 2005
K050310BARDPORT TITANIUM PORTSApril 18, 2005
K042445SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KITOctober 19, 2004
K971990GESCO PER-Q-CATH PICC CATHETERSNovember 7, 1997
K971991GESCO PER-Q-CATH MIDLINE CATHETERSNovember 7, 1997
K935380VASCULAR ACCESS CATHETER ACCESSORIESFebruary 17, 1995
K926139CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATHJanuary 3, 1995