Recall Z-2663-2026 ยท PND Midline Catheter
Bard Access Systems, Inc.
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.
| 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 | 2,844 |
| 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
| K162900 | PowerMidline Catheter C.R. Bard, Inc., Dec 14, 2016 |