Bard Access Systems, Inc.: Thoracentesis Tray
Recall Summary Bard Access Systems is recalling DuoGlide Short-Term Straight Dialysis Catheters (product 5625240) used to provide temporary vascular access for dialysis treatments. The recall affects catheters distributed nationwide and in Belgium because the lidocaine ampoules included in the trays were manufactured under deficient manufacturing practices. This is a Class II recall, meaning the product could cause serious health problems or death, though a serious adverse event has not necessarily occurred.
- Recalling firm
- Bard Access Systems, Inc.
- Product
- 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
- 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/79677f84-b87b-4d21-b5bf-529d569abf9e