Z-0361-2023 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 Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF 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 10884521009585 Case 20884521009582 Lot Numbers: 2216806064, 2214452064, 2212401164 2210219764, 2209525364, 2208816464 2206737964, 2206727564