Recall Z-2657-2026 ยท PXI Thoracentesis Tray
Bard Access Systems, Inc.
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.
| Date | Jul 2, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Root cause | Nonconforming Material/Component |
| Action | On 05/21/2026, the firm FedEx'd an "URGENT: Medical Device Recall" letter informing customers/distributed that BD has become aware that the FDA has placed Lidocaine manufactured by Huons Co., Ltd. on import alert #66-40 - Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. BD is recalling products that contain the affected lidocaine ampules. Customers are instructed to: 1. Not to use the affected Lidocaine ampules. 2. Secure an alternative local Lidocaine drug prior to entering the procedural environment. 3. Upon opening the kit, remove and destroy the dru |
| Quantity | 310 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030268 | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS C.R. Bard, Inc., Jul 30, 2003 |