Z-0360-2023 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: 3450 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 10884521009479 Case 20884521009476 Lot Numbers: 2216502264, 2216507864, 2215825864 2215119164, 2214451964, 2213740964 2213046464, 2212401364, 2212401264 2211101164, 2211101264, 2209515164 2210219664, 2209515264, 2209501064 2207800564, 2208816364, 2207401264 2207401164