Bard Access Systems, Inc.: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Recalling firm
Bard Access Systems, Inc.
Product
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1...
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/d5ea2db2-7525-4036-bd4b-1ad08ad2e289