FDA Medical devices recall · July 8, 2026

CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code:… recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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: RE

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2664-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.