Recall archive / FDA device enforcement
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 ... — FDA record Z-2667-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 21, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.
- Reason
- Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Classification
- Class II
- Recalling firm
- Bard Access Systems, Inc.
- Quantity
- 24,348
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2667-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 Lot Number: REKN2105 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 Lot Numbers: REKW2429 REKX1484 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 Lot Number: REKW2494 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 Lot Numbers: REKP0118 REKX2225 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 Lot Number: REKX3430 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 Lot Numbers: REKQ0118 REKW1477 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 Lot Number: REKY0144 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 Lot Numbers: REKW0447 REKW0953 REKX2214 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 Lot Number: REKX3445 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 Lot Number: REKW2430 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 Lot Numbers: REKV3192 REKX3437 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 Lot Number: REKW2448 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 Lot Number: REKW0959 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- 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
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 8, 2026
- Recall initiation date
- May 21, 2026
- Center classification date
- Jul 2, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.