Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY — Class I medical device recall Z-1047-2024
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-1047-2024 |
|---|---|
| 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 | 7,800 units |
| UPC / GTIN / UDI-DI | 10884521066953, 20884521066950 |
| Lot numbers | 2134203264, 2134203364, 2134218364, 2200118864, 2200118964, 2200428164, 2201116464, 2201116564, 2203928364, 2203928464, 2203931464, 2204633964, 2204634064, 2204636264, 2204636464, 2204636764, 2205315364, 2205315564, 2206013464, 2206013564, 2206013664, 2206725964, 2206726264, 2207402764, 2207402864, 2208814664, 2208814764, 2208814864, 2208814964, 2209524164, 2210218264, 2210218564, 2210218664, 2210218864, 2210901764, 2210901964, 2211626964, 2211801264, 2212321664, 2212321764 and 95 more |
Product
Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 14 FR (4.7 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M TEMP SENSE FOLEY TRAY, 16 FR (5.3 MM), 5 CC; Dover" 100% SILICONE 400 ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 18 FR (6.0 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, 14 FR (4.7 MM), 5 CC, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 16 FR (5.3 MM), 5CC, 2000ML DRAIN BAG, CSD; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE; Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
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-1047-2024. 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.