Device product
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
Z-0356-2023
Product summary
- Firm
- Cardinal Health
- Event
- Event 91087
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0356-2023
Official wording
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
Code information: UDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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