Food, drugs, devices › Bard Access Systems

Device recall: PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended fo

FDA enforcement event 70834 · Class II · initiated 13 Mar 2015 · status Terminated · terminated 24 Jun 2015

DeviceVoluntary: Firm initiated1 product recordSalt Lake City, UT

FDA enforcement event 70834 is a device recall by Bard Access Systems of Salt Lake City, UT, initiated 13 Mar 2015 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 24 Jun 2015. Initiation: voluntary: firm initiated. Bard Access Systems has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Bard Access Systems, Salt Lake City, UT.

Reason for recall

"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."

Distribution

"US Distribution to states of: GA and MN."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1560-2015	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 indicated for power injection of contrast media…	700 units	Class II	Terminated	6 May 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Bard Access Systems

Initiated	Product (first record)	Type	Class	Records
19 Dec 2016	MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in therm	Device	Class II	2
9 Dec 2016	StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad	Device	Class II	2
20 Jul 2015	Marketing brochures for the PowerPICC and PowerPICC SOLO catheters	Device	Class II	1
27 May 2015	PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo cat	Device	Class III	4
3 Nov 2014	GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Cod	Device	Class II	1
8 Aug 2014	BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lu	Device	Class II	5
24 Jun 2014	Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.	Device	Class II	1
27 Feb 2014	PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Produ	Device	Class II	1
6 Dec 2013	MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6	Device	Class II	2
10 Jun 2013	StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ devi	Device	Class II	1

All 13 events for Bard Access Systems

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution to states of: GA and MN."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.