Class 2 Device Recall PowerPICC Catheter

• Date Initiated by Firm: May 21, 2026
• Date Posted: July 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2666-2026
• Recall Event ID: 99096
• 510(K)Number: K210264
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222
• Code Information: 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 Lot Numbers: REKW0930 REKX0625 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 Lot Number: REKX2233 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 Lot Number: REKW2495 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 Lot Number: REKW0912 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 Lot Number: REKW0980 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 Lot Number: REKW2454 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 Lot Number: REKX0643 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 Lot Number: REKW1471 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 Lot Number: REKY0121 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 Lot Number: REKW0913 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 Lot Numbers: REKP1491 REKW1478 REKX0051 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 Lot Numbers: REKW0937 REKX0095 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 Lot Number: REKP0933 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 Lot Numbers: REKN0696 REKW0451 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 Lot Number: REKW2499 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 Lot Number: REKU2372 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 Lot Number: REKP0950 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 Lot Number: REKN2100 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 Lot Number: REKY1980 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 Lot Number: REKX0904 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 Lot Number: REKW2466 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 Lot Number: REKX3758 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 Lot Number: REKX1896 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 Lot Number: REKW2474 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 Lot Number: REKP0918 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 Lot Numbers: REKW0468 REKX2706 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 Lot Number: REKX0941 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 Lot Number: REKY1950 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 Lot Number: REKX0671 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 Lot Number: REKX0661 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 Lot Number: REKW1459 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 Lot Number: REKW1476 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 Lot Number: REKW0911 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 Lot Number: REKW0473 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 Lot Number: REKX0641 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 Lot Number: REKW1470 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 Lot Number: REKW2521 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 Lot Number: REKW2446 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 Lot Number: REKW0475 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 Lot Numbers: REKW2522 REKX2212 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 Lot Number: REKX2224 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 Lot Number: REKX0073 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222 Lot Number: REKX0144
• FEI Number: 3006260740
• Recalling Firm/ Manufacturer: Bard Access Systems, Inc.; 605 N 5600 W; Salt Lake City UT 84116-3738
• For Additional Information Contact: Adam Daniels; 385-583-9999
• Manufacturer Reason for Recall: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
• FDA Determined 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 drug product from the BD convenience kits/procedure trays at the point of use, within a controlled and sterile environment to maintain the sterility of the remaining components within the kit. All other kit/tray components are safe to use. 4. If affected Lidocaine ampule was previously used without issue, no additional treatment or clinical follow up is required. 5. If affected Lidocaine ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions. Additional actions to take: 1. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2. Post this notice on all inventory storage locations and any location where the product may be used. 3. Label affected kits/trays using the template provided in Appendix 2 to facilitate easy identification of products containing the affected ampules. The label can be printed using Avery template 5160. a. Apply the labels to the product without covering or obscuring any regulatory or traceability information. b. Apply to the top web of the kit/tray pressing firmly to ensure adhesion, while taking care not to damage or compromise the sterile barrier. For Questions - Contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompt
• Quantity in Commerce: 39,245
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LJS