Bard Access Systems, Inc.: Midline Catheter
Recall Summary Bard Access Systems is recalling PowerMidline Catheters (used for intravenous therapy and blood draws) because the lidocaine anesthetic included with these catheters was manufactured under substandard conditions. The affected catheters were distributed nationwide across the U.S. and in Belgium.
- Recalling firm
- Bard Access Systems, Inc.
- Product
- CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
- 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/b41753ce-dbee-4880-ae63-8fc863753453