Food, drugs, devices › Bard Access Systems Inc.

Device recall: 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with

FDA enforcement event 88048 · Class II · initiated 19 May 2021 · status Terminated · terminated 24 Jan 2023

DeviceVoluntary: Firm initiated1 product recordSalt Lake City, UT

FDA enforcement event 88048 is a device recall by Bard Access Systems Inc. of Salt Lake City, UT, initiated 19 May 2021 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 24 Jan 2023. Initiation: voluntary: firm initiated. Bard Access Systems Inc. has 10 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 Inc., Salt Lake City, UT.

Reason for recall

"Catheter kits contained the incorrect micro-introducers."

Distribution

"U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1991-2021	5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer	180 units	Class II	Terminated	7 Jul 2021

Context

89%of 2021 device events are Class II900 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Bard Access Systems Inc.

Initiated	Product (first record)	Type	Class	Records
10 Aug 2026	Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Cathet	Device	Class I	2
30 Jul 2026	BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251	Device	Class I	1
21 May 2026	OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI C	Device	Class II	14
11 Mar 2025	BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118	Device	Class I	1
20 Jun 2022	Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/	Device	Class I	1
19 May 2021	5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPI	Device	Class II	1
7 Apr 2021	REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Produc	Device	Class II	18
28 Dec 2017	PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a	Device	Class II	1
25 Apr 2017	StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in	Device	Class II	1

All 10 events for Bard Access Systems Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Catheter kits contained the incorrect micro-introducers."

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: "U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Jan 2023. "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.