Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch — Class II medical device recall Z-0360-2023
Ongoing recall by Cardinal Health, reported 2022-12-14, distributed nationwide. Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining int
| Recall number | Z-0360-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Mansfield, MA, United States |
| Recall initiated | 2022-11-01 |
| Classified | 2022-12-02 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10884521009479, 20884521009476 |
| Lot numbers | 2207401164, 2207401264, 2207800564, 2208816364, 2209501064, 2209515164, 2209515264, 2210219664, 2211101164, 2211101264, 2212401264, 2212401364, 2213046464, 2213740964, 2214451964, 2215119164, 2215825864, 2216502264, 2216507864 |
Product
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
Reason for recall
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
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-0360-2023. 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.