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Bard Access Systems, Inc.

United States·US-MF-000017720

Last updated September 17, 2026

What Bard Access Systems, Inc. makes

Bard Access Systems, Inc. manufactures peripherally-inserted central venous catheters, including midline and hemodialysis variants, as well as vascular port administration sets and catheters. Their portfolio also includes vascular intervention infusion catheters, wearable percutaneous catheter/tube holders, and electrocardiographic/magnetic navigation systems for central venous catheter placement. Additionally, they produce general-purpose ultrasound imaging systems and accessories for vascular port needle insertion.

The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Bard Access Systems, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 605 North, 5600 West, Salt Lake City, United States
Website: No website
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 801 230 5783
PRRC Contact: Nitin Patil
EUDAMED SRN: US-MF-000017720
FDA FEI Number: 3006260740
DUNS Number: —

Catalogue (4044)

Page 20 of 81

Device	Model / Reference	Registries	Class	Status
Site-Rite	USv1.1.0	FDA UDI	Class II	Active
Poly Per-Q-Cath Catheter	3255107	FDA UDI	Class II	Active
Port Access Needle	SHW19-150YS	FDA UDI	Class II	Active
Port Access Needle	SH19-75Y	FDA UDI	Class II	Active
Navarre Opti-Drain	NOD8PT	FDA UDI	Class I	Active
Securis	SECNS01	FDA UDI	Class I	Active
Peripheral Catheter Insertion Kit	F220108PT	FDA UDI	Class II	Active
PowerPICC Provena	S1274108D7	FDA UDI	Class II	Active
Decathlon DF Long-Term Hemodialysis Catheter	DF35IT40K	FDA UDI	Class II	Active
PowerPICC SOLO	CK000414B	FDA UDI	Class II	Active
Brevia catheter	5494120	FDA UDI	Class II	Active
HemoStar Long-Term Hemodialysis Catheter	5835150	FDA UDI	Class II	Active
PowerPICC	CK000417A	FDA UDI	Class II	Unknown
BardPort	0602290	FDA UDI	Class II	Active
PowerPICC Provena	CK000823	FDA UDI	Class II	Active
HemoSplit Long-Term Hemodialysis Catheter	5733690	FDA UDI	Class II	Active
X-Port isp M.R.I.	0657520	FDA UDI	Class II	Active
Port Access Needle	SHG619-150YS	FDA UDI	Class II	Active
MiniLoc	CPA00041	FDA UDI	Class II	Active
PowerPort M.R.I, Groshong	1808580	FDA UDI	Class II	Active
Per-Q-Cath	CK000106	FDA UDI	Class II	Active
Navarre	NNU6PT	FDA UDI	Class I	Active
PowerPICC Provena SOLO	CK000409A	FDA UDI	Class II	Active
PowerPICC Provena	CK001050	FDA UDI	Class II	Active
Poly Per Q Cath	CK000113A	FDA UDI	Class II	Active
Power-Trialysis catheter	5605240	FDA UDI	Class II	Active
Bard Button Replacement Gastrostomy Device	000296	FDA UDI	Class II	Unknown
PowerPICC	CK000758	FDA UDI	Class II	Active
X-Port isp M.R.I.	0607555	FDA UDI	Class II	Active
PowerPICC Provena	S1274108PD	FDA UDI	Class II	Active
Port Access Needle	SH19-100Y	FDA UDI	Class II	Active
Port Access Kit	2131915G	FDA UDI	Class II	Active
PowerPICC	CK000293	FDA UDI	Class II	Active
Port Access Needle	S02119-75	FDA UDI	Class II	Unknown
Sherlock	Sherlockv1.1.0	FDA UDI	Class II	Active
PowerPICC	CK000188C	FDA UDI	Class II	Active
Port Access Kit	2681915G	FDA UDI	Class II	Active
PowerPICC SOLO	CK000609	FDA UDI	Class II	Active
CentroVena	1RG07216	FDA UDI	Class II	Active
Per-Q-Cath	CK000478	FDA UDI	Class II	Active
Vaccess Lt Long-Term Hemodialysis Catheter	5123150	FDA UDI	Class II	Unknown
PowerPort ClearVUE	1678300	FDA UDI	Class II	Active
Bard Poly Midline	CK000122B	FDA UDI	Class II	Active
HemoSplit Long-Term Hemodialysis Catheter	5733274	FDA UDI	Class II	Active
Port Access Needle	S02122-10	FDA UDI	Class II	Unknown
PowerPICC SOLO2 Catheter	3295108D	FDA UDI	Class II	Active
X-Port isp, ChronoFlex	0608530	FDA UDI	Class II	Active
PowerPICC	CK000287B	FDA UDI	Class II	Active
PowerPICC	CK000443B	FDA UDI	Class II	Active
PowerPICC	CK000285C	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (76)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Bard Access Systems, Inc. has 76 recall records initiated between September 23, 2003, and March 11, 2025. The recalls include instances of compromised sterility due to open seals or improper packaging, incorrect sizing of components such as retainer clips or introducers, missing or misprinted pages in instruction booklets, and discrepancies in product labeling. Statuses recorded include open, classified, and terminated recalls, with reasons spanning packaging defects, labeling errors, and potential deviations in product specifications.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 11, 2025	Z-1507-2025	—	open, classified	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.
Jun 20, 2022	Z-1397-2022	—	open, classified	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.
May 19, 2021	Z-1991-2021	—	terminated	Catheter kits contained the incorrect micro-introducers.
May 19, 2021	Z-1994-2021	—	terminated	Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Apr 7, 2021	Z-1661-2021	—	terminated	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
Apr 7, 2021	Z-1667-2021	—	terminated	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
Apr 7, 2021	Z-1653-2021	—	terminated	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
Apr 7, 2021	Z-1668-2021	—	terminated	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
Apr 7, 2021	Z-1655-2021	—	terminated	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
Apr 7, 2021	Z-1659-2021	—	terminated	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
Apr 7, 2021	Z-1652-2021	—	terminated	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
Apr 7, 2021	Z-1662-2021	—	terminated	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
Apr 7, 2021	Z-1658-2021	—	terminated	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
Apr 7, 2021	Z-1656-2021	—	terminated	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
Apr 7, 2021	Z-1657-2021	—	terminated	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
Apr 7, 2021	Z-1664-2021	—	terminated	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
Apr 7, 2021	Z-1666-2021	—	terminated	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
Apr 7, 2021	Z-1654-2021	—	terminated	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
Apr 7, 2021	Z-1660-2021	—	terminated	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
Apr 7, 2021	Z-1669-2021	—	terminated	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
Apr 7, 2021	Z-1665-2021	—	terminated	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
Apr 7, 2021	Z-1663-2021	—	terminated	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
Dec 28, 2017	Z-0536-2018	—	terminated	Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Apr 25, 2017	Z-2120-2017	—	terminated	StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Dec 19, 2016	Z-0986-2017	—	terminated	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.
Dec 19, 2016	Z-0985-2017	—	terminated	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.
Dec 9, 2016	Z-0981-2017	—	terminated	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.).
Dec 9, 2016	Z-0982-2017	—	terminated	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.).
Jul 20, 2015	Z-2808-2015	—	terminated	Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure.
May 27, 2015	Z-2048-2015	—	terminated	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
May 27, 2015	Z-2050-2015	—	terminated	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
May 27, 2015	Z-2047-2015	—	terminated	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
May 27, 2015	Z-2049-2015	—	terminated	Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Mar 13, 2015	Z-1560-2015	—	terminated	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.
Nov 3, 2014	Z-0493-2015	—	terminated	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.
Aug 8, 2014	Z-1273-2015	—	terminated	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.
Aug 8, 2014	Z-1272-2015	—	terminated	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.
Aug 8, 2014	Z-1275-2015	—	terminated	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.
Aug 8, 2014	Z-1274-2015	—	terminated	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.
Aug 8, 2014	Z-1271-2015	—	terminated	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.
Jun 24, 2014	Z-1443-2015	—	terminated	Potential for inadvertent scalpel stick injury involving the safety scalpel.
Feb 27, 2014	Z-1300-2014	—	terminated	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.
Dec 6, 2013	Z-0815-2014	—	terminated	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.
Dec 6, 2013	Z-0814-2014	—	terminated	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.
Jun 10, 2013	Z-1618-2013	—	terminated	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 may impact the securement of the cathet
Feb 21, 2013	Z-0909-2013	—	terminated	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.
Feb 21, 2013	Z-0910-2013	—	terminated	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.
Aug 7, 2012	Z-2277-2012	—	terminated	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.
Feb 16, 2012	Z-1133-2012	—	terminated	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.
Aug 30, 2011	Z-3173-2011	—	terminated	Implanted port has discrepant product information on package labeling.
Jun 21, 2011	Z-2782-2011	—	terminated	Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
Jun 20, 2011	Z-2783-2011	—	terminated	Kit label indicates the wrong dimension for an enclosed introducer.
May 21, 2011	Z-2960-2011	—	terminated	Labeling for drainage kit contained incomplete information.
May 21, 2011	Z-2961-2011	—	terminated	Labeling for drainage kit contained incomplete information.
May 21, 2011	Z-2962-2011	—	terminated	Labeling for drainage kit contained incomplete information.
May 21, 2011	Z-2959-2011	—	terminated	Labeling for drainage kit contained incomplete information.
Dec 10, 2010	Z-0865-2011	—	terminated	Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
Mar 18, 2010	Z-1525-2010	—	terminated	8F PowerPort stems were mixed with 6F PowerPorts and packaged.
Jan 14, 2010	Z-0861-2010	—	terminated	After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
Jan 14, 2010	Z-0862-2010	—	terminated	After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
Apr 6, 2006	Z-0839-06	—	terminated	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 carries the risk of infection.
Apr 6, 2006	Z-0837-06	—	terminated	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 carries the risk of infection.
Apr 6, 2006	Z-0836-06	—	terminated	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 carries the risk of infection.
Apr 6, 2006	Z-0838-06	—	terminated	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 carries the risk of infection.
Dec 20, 2005	Z-0541-06	—	terminated	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.
Dec 20, 2005	Z-0542-06	—	terminated	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.
Dec 20, 2005	Z-0544-06	—	terminated	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.
Dec 20, 2005	Z-0543-06	—	terminated	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.
Nov 3, 2004	Z-0715-05	—	terminated	Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Nov 3, 2004	Z-0714-05	—	terminated	Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Nov 3, 2004	Z-0720-05	—	terminated	Conductivity gel pouches, labeled as sterile, may not be sterile.
Nov 3, 2004	Z-0717-05	—	terminated	Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Nov 3, 2004	Z-0716-05	—	terminated	Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Nov 3, 2004	Z-0719-05	—	terminated	Conductivity gel pouches, labeled as sterile, may not be sterile.
Nov 3, 2004	Z-0718-05	—	terminated	Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile.
Sep 23, 2003	Z-0098-04	—	terminated	Sterility of product is compromised by open seals in packaging.