FreshRecalls

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FDAClass II · Medical device · Recalled July 8, 2026

CK000495A Poly Midline Catheter 4 Fr Single-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-2656-2026
Brand
Bard Access Systems
Classification
Class II
Units affected
3,240
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

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
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965
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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