Dover" 100% SILICONE 400 ML U/M FOLEY TRAY — Class I medical device recall Z-1048-2024
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-1048-2024 |
|---|---|
| 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 | 195,600 units |
| UPC / GTIN / UDI-DI | 10884521174061, 10884521174078, 20884521174068, 20884521174075 |
| Lot numbers | 2134218264, 2134218564, 2200603564, 2201151164, 2201201664, 2202401464, 2203300964, 2203931664, 2205315264, 2206726164, 2209524264, 2210218464, 2211031564, 2211626864, 2213045564, 2213738964, 2214449364, 2215117864, 2215824164, 2215824364, 2216500464, 2216805064, 2217920064, 2219400664, 2231213064, 2231213164, 2231213564, 2231901164, 2231901264, 2232517864, 2300202064, 2301703364, 2303006964, 2303007064, 2303822464, 2304400364, 2304400464, 2305206264, 2307110664, 2308004464 and 15 more |
Product
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE
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-1048-2024. 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.