FDA Device recall Z-1871-2025
Catalog No. 8888160325
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Catalog No. 8888160325 by Cardinal Health 200, citing packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1871-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-02 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Reason
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Identifiers
| code_info | UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1871-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.