FreshRecalls

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FDAClass II · Medical device · Recalled July 8, 2026

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code recall — Bard Access Systems, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2663-2026
Brand
Bard Access Systems
Classification
Class II
Units affected
2,844
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Affected products

Companies & origin

Recalling firm location
Salt Lake City, UT, United States
Firm address
605 N 5600 W, N/A, 84116-3738

Identifying details (verbatim from the notice)

Product codes / lots
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 Lot Number: REKX0112 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 Lot Number: REKW0949 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 Lot Number: REJZ1337
Distribution
Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Firm notified the public via
Letter
FDA event ID
99096
Recall initiated
May 21, 2026
FDA classified
July 2, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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