FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard PowerPICC SV catheters recalled due to deficient lidocaine manufacturing
What this means
Bard Access Systems is recalling PowerPICC SV catheters (both 3 Fr and 4 Fr models) because the lidocaine ampoules included with these catheters were manufactured under deficient practices. These catheters are used for central venous access during intravenous therapy and blood sampling.
- Check if you have affected lots: 4 Fr model REKW2449 or 3 Fr model REKV2227
- Contact your healthcare provider or hospital if you received one of these catheters
- Do not use the lidocaine ampoules included with recalled units
- Return affected units to your supplier or manufacturer for instructions
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
624
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2659-2026More 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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