Catalog No — Class II medical device recall Z-1873-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-06-04, distributed nationwide. Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could le
| Recall number | Z-1873-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2025-05-02 |
| Classified | 2025-05-29 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CL, CO, SG, ZA |
| Quantity | 51,378 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10192253040319, 50192253040317 |
| Lot numbers | 2404400061, 2404400062, 2404400065, 2412100093, 2412100096, 2415100093, 2415100106, 2415100107, 2415100109, 2415100110, 2415100111, 2415100112, 2415100113, 2415100114, 2415100115, 2415100116, 2425600063, 2425600064, 2425600065, 2425600066, 2425600067, 2425600069, 2425600070, 2425600071, 2425600072, 2425600073, 2425600074, 2425600075, 2425600076, 2425600077, 2427700158, 2427700159, 2427700160, 2433000005, 2433000094, 2433000095 |
| Model numbers | 8888160341 |
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Reason for recall
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
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-1873-2025. 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.