Cardinal Health: Medical Device Recall in 2022 - (Recall #: Z-0357-2023)

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 16 Fr/Ch (5.3 mm) Product Code: 3408 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-0357-2023

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 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated