Bard Access Systems, Inc.: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen), which are used for long-term intravenous access and blood sampling, because the lidocaine ampoules included with the product were manufactured under inadequate quality control practices. The recall affects products distributed nationwide in the U.S. and in Belgium. This is a Class II recall, meaning there is potential for serious adverse health effects.
- Recalling firm
- Bard Access Systems, Inc.
- Product
- 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or 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/e54e57e3-f453-4314-beb3-cdcb2b21d86f