Cardinal Health: Medical Device Recall in 2022 - (Recall #: Z-0358-2023)

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 Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 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-0358-2023

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 10884521009448 Case 20884521009445 Lot Numbers: 2216502164, 2215825764, 2215122964 2213740864, 2209525264, 2210223764

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated