Cardinal Health: Medical Device Recall in 2022 - (Recall #: Z-0360-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 1, 2022

Date Posted: December 14, 2022

Recall Number: Z-0360-2023

Event ID: 91087

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

Status: Ongoing

Product Quantity: N/A

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated