Recall Z-0360-2023— Cardinal Health

Name: FDA recall Z-0360-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-01

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health, initiated 2022-11-01. It names one FDA 510(k) clearance: K903340. Product: 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: 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.

Recalling firm: Cardinal Health
Classification: Class II
Status: Ongoing
Initiated: 2022-11-01
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K903340 — STERILE URETHRAL CATHETER PROCEDURE KITSSuperior Healthcare Group, Inc.·cleared 1990-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.