FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard Access Systems Poly Midline Catheter recalled for deficient lidocaine ampoule manufacturing
What this means
Bard Access Systems is recalling Poly Midline Catheter kits (models CK000495A and CK000566) because the lidocaine ampoules included with them were manufactured under deficient practices. These catheters are used for short- or long-term peripheral venous access in hospitals and clinical settings.
- If you work in a healthcare facility, check your supply of affected catheter kits (lot numbers REKV1588, REKX0938, and REKY1965)
- Do not use kits with the recalled lot numbers
- Contact your supplier or Bard Access Systems for instructions on replacement or return
The agency's original wording
Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
3,240
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2656-2026More Bard Access Systems, Inc. recalls
- FDA-Device2026-07-08Bard Access Systems Power-Trialysis dialysis catheters recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Access Systems PowerPICC catheters recalled for deficient lidocaine manufacturing
- FDA-Device2026-07-08Bard Access Systems soft tissue biopsy trays recalled for defective lidocaine ampoules
- FDA-Device2026-07-08Bard Access Systems PowerMidline Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Groshong NXT ClearVue Catheter recalled for deficient lidocaine ampoule manufacturing
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