Manufacturer

Bard Access Systems

24 recalls in our database name Bard Access Systems as the manufacturing or recalling firm.

What the numbers show

Total: 24
Critical: 0
Severe: 0
Most recent: 2017-01-18

Of the 24 recalls from Bard Access Systems we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–24 of 24

ModerateFDA (Devices)·Z-0982-2017·2017-01-18
Bard Access Systems Recalls StatLock Catheter Stabilization Devices
Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.
Product
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. 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 carton and 10 cartons per case. Other configurations may contain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2017·2017-01-18
Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
Bard Access Systems is recalling SafeStep Huber Needle Sets because some units may have needle lengths or gauges that differ from the label.
Product
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through s
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0985-2017·2017-01-18
Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
Bard Access Systems is recalling MiniLoc Safety Infusion Sets because some units have needle lengths and gauges that differ from the label descriptions.
Product
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 the administration of fluids and drugs, or blood samplin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0981-2017·2017-01-18
Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
Bard Access Systems is recalling StatLock PICC Plus Crescent Foam devices because some pouches lack unique product identifiers like lot numbers.
Product
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 carton and 10 cartons per case. Other configurations may co
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2808-2015·2015-09-30
Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures
Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.
Product
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2047-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.
Product
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 intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2049-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheters for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels display incorrect expiration dates.
Product
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2048-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because they have incorrect expiration dates on the primary labeling.
Product
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2050-2015·2015-07-15
Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.
Product
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1560-2015·2015-05-06
Bard Access Systems Recalls PowerLoc MAX Safety Winged Infusion Set
Bard Access Systems is recalling 700 units of the PowerLoc MAX Safety Winged Infusion Set due to a potential incorrect Maximum Flow rate label on the packaging.
Product
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 implanted vascular ports. The PowerLoc MAX SWIS is also indicat
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1443-2015·2015-04-22
Bard PICC and Dialysis Catheter Kits Recalled for Scalpel Injury Risk
Bard Access Systems is recalling PICC and dialysis catheter kits containing Safe-Cut Safety Scalpels due to the potential for inadvertent scalpel stick injuries.
Product
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.
Product
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 Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1272-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, Power
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1274-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1275-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0493-2015·2014-12-10
Bard Access Systems Recalls Non-Sterile GuardIVa Antimicrobial Hemostatic IV Dressing
Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.
Product
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1300-2014·2014-04-02
Bard Access Systems Recalls PowerPort Slim Implantable Ports Due to Labeling Error
Bard Access Systems is recalling 777 PowerPort Slim Implantable Ports because the labels incorrectly state they contain silicone suture plugs, when some units do not.
Product
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0815-2014·2014-01-29
Bard Access Systems Recalls Low Profile Ports with Undersized Catheters
Bard Access Systems is recalling Low Profile Ports with 6.6 Fr catheters because some silicone catheters may be undersized to 5.3 Fr.
Product
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0814-2014·2014-01-29
Bard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters
Bard Access Systems is recalling MRI Low Profile Single Lumen ports because some silicone catheters may be undersized to 5.3 Fr instead of the labeled 6.6 Fr.
Product
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 goods as Attachable or Preconnected catheters in BardPort I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1618-2013·2013-07-10
Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error
Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.
Product
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.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0910-2013·2013-03-13
Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size
Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.
Product
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0909-2013·2013-03-13
Bard Access Systems Recalls Hickman and Leonard Catheters Due to Wrong Introducer Size
Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.
Product
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 Catheters are designed for long-term vascular access and fo
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2277-2012·2012-09-05
Bard Access Systems Recalls HemoStar XK Hemodialysis Catheters for Incorrect Expiration Date
Bard Access Systems is recalling 120 units of 16 Fr HemoStar XK Long-Term Hemodialysis Catheters because they were labeled with an incorrect expiration date.
Product
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 polyurethane and allows for flow rates as high as 500 ml/min d
Category
Medical Device
Distribution
16 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Bard Access Systems (United States)

company in Salt Lake City, United States

Country: United States
Founded: 1983

Official website

Source: Wikidata (Q104479981), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.