FDA Device recall Z-0360-2023
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 In…
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of 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 In… by Cardinal Health, citing 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 appropri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0360-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-01 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI: Each 10884521009479 Case 20884521009476 Lot Numbers: 2216502264, 2216507864, 2215825864 2215119164, 22…UDI-DI: Each 10884521009479 Case 20884521009476 Lot Numbers: 2216502264, 2216507864, 2215825864 2215119164, 2214451964, 2213740964 2213046464, 2212401364, 2212401264 2211101164, 2211101264, 2209515164 2210219664, 2209515264, 2209501064 2207800564, 2208816364, 2207401264 2207401164 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0360-2023%22
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