CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code:… — Class II medical device recall Z-2667-2026
Ongoing recall by Bard Access Systems, Inc., reported 2026-07-08, distributed nationwide. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain
| Recall number | Z-2667-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE |
| Quantity | 24,348 |
| UPC / GTIN / UDI-DI | 00801741153952, 00801741153990, 00801741154003, 00801741154027, 00801741154119, 00801741154140, 00801741154164, 00801741154188, 00801741185052, 00801741185069, 00801741188770, 00801741233234, 00801741233258 |
| Lot numbers | REKN2105, REKP0118, REKQ0118, REKV3192, REKW0447, REKW0953, REKW0959, REKW1477, REKW2429, REKW2430, REKW2448, REKW2494, REKX1484, REKX2214, REKX2225, REKX3430, REKX3437, REKX3445, REKY0144, S4153108BDP, S4153108BP, S4153108D, S4153108DCP, S4153108DGP, S4254108BD, S4254108BDP, S4254108D, S4254108DCP, S4254108DGP, SP4153108D, SP4153108DG |
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 for recall
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2667-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.