Recall Z-2658-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2658-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Bard Access Systems, Inc., initiated 2026-05-21. It names one FDA 510(k) clearance: K091324. Product: CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.. Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier..

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K091324 — SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLETC.R. Bard, Inc.·cleared 2009-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

Reason for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.