Z-0358-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- November 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
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
Distribution Pattern
Nationwide
Code Information
UDI-DI: Each 10884521009448 Case 20884521009445 Lot Numbers: 2216502164, 2215825764, 2215122964 2213740864, 2209525264, 2210223764