Cardinal Health: Medical Device Recall in 2022 - (Recall #: Z-0361-2023)

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: 3450LF 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-0361-2023

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 10884521009585 Case 20884521009582 Lot Numbers: 2216806064, 2214452064, 2212401164 2210219764, 2209525364, 2208816464 2206737964, 2206727564

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated