CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK00088...
FDA Device Recall #Z-2664-2026 - Class II, May 21, 2026
Recall Summary
| Recall Number | Z-2664-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 21, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Access Systems, Inc. |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 29,490 |
Product Description
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used.
Reason for Recall
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Distribution Pattern
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.
Lot / Code Information
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 Lot Numbers: REKW2510 REKX3786 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 Lot Number: REKX3767 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 Lot Number: REKX0133 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 Lot Number: REKY1171 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 Lot Number: REKX0087 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 Lot Number: REKW1569 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 Lot Number: REKX3449 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 Lot Number: REKU2923 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 Lot Numbers: REKV3208 REKW2482 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 Lot Number: REKX0070 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 Lot Number: REKY0141 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 Lot Number: REKV3188 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 Lot Numbers: REKV3240 REKW0961 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 Lot Number: REKW1468 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 Lot Numbers: REKV3256 REKY1690 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 Lot Number: REKW1461 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 Lot Number: REKW2520 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 Lot Number: REKW1458 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 Lot Number: REKV2247 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 Lot Numbers: REKW0952 REKX2229 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 Lot Numbers: REKW1469 REKX0072 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 Lot Numbers: REKW1462 REKX0143 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 Lot Number: REKV3241 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 Lot Number: REKX1638 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 Lot Number: REKW0965
Other Recalls from Bard Access Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2872-2026 | Class I | BD Needle Kit for Powered Driver 15mm x 15Ga, R... | Jul 30, 2026 |
| Z-2657-2026 | Class II | 5625240 DuoGlide Short-Term Straight Dialysis C... | May 21, 2026 |
| Z-2656-2026 | Class II | CK000495A Poly Midline Catheter 4 Fr Single-Lum... | May 21, 2026 |
| Z-2661-2026 | Class II | 5855240 Power-Trialysis Slim-Cath Straight Shor... | May 21, 2026 |
| Z-2662-2026 | Class II | CK000727 PowerMidline Catheter 4 Fr Single-Lume... | May 21, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.