Recall Z-2660-2026 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Bard Access Systems, Inc.
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter
| 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 | 8,795 |
| 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
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. Bard, Inc., Sep 24, 2014 |