BD 4 Fr Single-Lumen PowerPICC Catheters — Class I medical device recall Z-1507-2025
Ongoing recall by Bard Access Systems, Inc., reported 2025-04-23, distributed nationwide. Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt
| Recall number | Z-1507-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2025-03-11 |
| Classified | 2025-04-16 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, IE, IL, IN, IT, JO, JP, KR, KW, LU, MX, NL, NO, NZ, PK, PL, PT, QA, SE, SI, SK, TR, TW, VN, ZA |
| Quantity | 718,461 |
| Reason classes | foreign material, packaging |
| UPC / GTIN / UDI-DI | 00801741027574, 00801741027581, 00801741027598, 00801741027604, 00801741027611, 00801741027628, 00801741027635, 00801741027710, 00801741027727, 00801741027741, 00801741027758, 00801741027765, 00801741027772, 00801741027789, 00801741028595, 00801741028618, 00801741028731, 00801741028847, 00801741034442, 00801741034459, 00801741034466, 00801741034503, 00801741034510, 00801741035548, 00801741035555 and 81 more |
| Lot numbers | REHV2765, REJN4145 |
| Model numbers | 1174108, 1174108D, 1174108D1, 1174108D2, 1174108D3, 1174108D4, 1174108D5, 1174118, 1194108, 1194108D, 1194108D1, 1194108D2, 1194108D3, 1194108D4, 1194108D5, 2174108, 3174108, 3174108D, 3174118, 3174135, 3174155, 3174335, 3174355, 3194108, 3194108D and 81 more |
Product
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784
Reason for recall
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
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-1507-2025. 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.