Dover" 100% SILICONE FOLEY TRAY — Class I medical device recall Z-1052-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2024-02-28. Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse A
| Recall number | Z-1052-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-12-04 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Countries outside the US | JP |
| Quantity | 924 units |
| UPC / GTIN / UDI-DI | 10884521003521, 20884521003528 |
| Lot numbers | 2211627364, 22210206164, 2231919964 |
Product
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
Reason for recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
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-1052-2024. 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.