Device product
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
Z-0358-2023
Product summary
- Firm
- Cardinal Health
- Event
- Event 91087
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0358-2023
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 10884521009448 Case 20884521009445 Lot Numbers: 2216502164, 2215825764, 2215122964 2213740864, 2209525264, 2210223764
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