Chrysalis Intelligence · Sponsors · Bard Access Systems, Inc.

Bard Access Systems, Inc.

Salt Lake Ciy,, UT, US · 8 510(k) clearances · 25 recalls (5 Class I)

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Total clearances
8
2021-07-30 → 2025-09-05
Last 12 months
0
Product codes
5
Most recent
2025-09-05
Name variants in FDA filings: Bard Access Systems / Bard Access Systems, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular Class II General Hospital 3 2025-09-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II General Hospital 2 2022-08-24
PTI Non-Coring (Huber) Needle Class II General Hospital 1 2024-11-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Class II Radiology 1 2024-02-18
MHC Needle, Interosseous Class II General Hospital 1 2022-11-10
Safety

Recalls (25)

Class I (serious)
5
Risk of injury / death
Total recalls
25
Currently ongoing
5
Most recent
2026-08-10
DateSeverityStatusRecall # ProductCodeReason
2026-08-10 Class I Ongoing Z-2985-2026 DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625… — this is a downstream recall of class I recall RES 98777
2026-08-10 Class I Ongoing Z-2984-2026 Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Cath… — this is a downstream recall of class I recall RES 98777
2026-07-30 Class I Ongoing Z-2872-2026 BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D01525… — After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary …
2025-03-11 Class I Ongoing Z-1507-2025 BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118… — Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lea…
2022-06-20 Class I Ongoing Z-1397-2022 Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D0151… — BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the ent…
2021-05-19 Class II Terminated Z-1994-2021 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD… — Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
2021-05-19 Class II Terminated Z-1991-2021 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC … — Catheter kits contained the incorrect micro-introducers.
2021-04-07 Class II Terminated Z-1669-2021 REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage:… — 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 an…
2021-04-07 Class II Terminated Z-1668-2021 REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage:… — 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 an…
2021-04-07 Class II Terminated Z-1667-2021 REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single… — 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 an…
2021-04-07 Class II Terminated Z-1666-2021 REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen,… — 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 an…
2021-04-07 Class II Terminated Z-1665-2021 REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, S… — 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 an…
2021-04-07 Class II Terminated Z-1664-2021 REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen… — 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 an…
2021-04-07 Class II Terminated Z-1663-2021 REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen,… — 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 an…
2021-04-07 Class II Terminated Z-1662-2021 REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Si… — 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 an…
2021-04-07 Class II Terminated Z-1661-2021 REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, … — 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 an…
2021-04-07 Class II Terminated Z-1660-2021 REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, … — 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 an…
2021-04-07 Class II Terminated Z-1659-2021 REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen,… — 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 an…
2021-04-07 Class II Terminated Z-1658-2021 REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, U… — 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 an…
2021-04-07 Class II Terminated Z-1657-2021 REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usag… — 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 an…
2021-04-07 Class II Terminated Z-1656-2021 REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage… — 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 an…
2021-04-07 Class II Terminated Z-1655-2021 REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Pr… — 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 an…
2021-04-07 Class II Terminated Z-1654-2021 REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage:… — 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 an…
2021-04-07 Class II Terminated Z-1653-2021 REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usag… — 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 an…
2021-04-07 Class II Terminated Z-1652-2021 REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Produc… — 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 an…
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2025-09-05 K252478 Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port LJT Class II General Hospital
2025-06-18 K251253 PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port LJT Class II General Hospital
2024-11-27 K241353 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set PTI Class II General Hospital
2024-10-31 K242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports LJT Class II General Hospital
2024-02-18 K240146 BD Prevue™ II Peripheral Vascular Access System IYO Class II Radiology
2022-11-10 K223198 BD Intraosseous Vascular Access System EMS Powered Driver (D001003) MHC Class II General Hospital
2022-08-24 K222232 Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly LJS Class II General Hospital
2021-07-30 K210264 BD PowerPiCC Catheter LJS Class II General Hospital
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence