Dover" 100% SILICONE FOLEY TRAY — Class I medical device recall Z-1050-2024
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-1050-2024 |
|---|---|
| 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 | 4,620 units |
| UPC / GTIN / UDI-DI | 10884521015500, 10884521143340, 20884521143347, 30884521015504 |
| Lot numbers | 2203933464, 2206721364, 2206721464, 2206723564, 2206723664, 2207404564, 2207803464, 2207805664, 2208817564, 2209525664, 2209525964, 2210210364, 2210210464, 2210904064, 2211628464, 2212321564, 2212323064, 2212323864, 2213047764, 2213048664, 2213741964, 2214452664, 2215116164, 2215120464, 2215826764, 2216503164, 2222830564, 2223120264, 2223542964, 2223543064, 2225100964, 2231220064, 2231912364, 2232102364, 2232601264, 2234606164, 2300129064, 2300129264, 2303011264, 2305403264 and 5 more |
Product
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 18 FR (6.0 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER-LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG
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-1050-2024. 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.