Bard Access Systems, Inc.: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Recall Summary Bard Access Systems is recalling PowerPICC SV catheters (both 3 Fr single-lumen and 4 Fr dual-lumen models) used for long-term intravenous access and blood sampling. The recall affects catheters distributed nationwide and in Belgium due to the lidocaine ampoules included with them being manufactured under substandard conditions. This is a Class II recall affecting patients who received or may use these specific catheter products.
- Recalling firm
- Bard Access Systems, Inc.
- Product
- 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.
- Reason
- Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a858943c-26cd-4986-bd84-10e2ba39377f