Recall Z-0361-2023— Cardinal Health

Name: FDA recall Z-0361-2023
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: 3450LF 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: 3450LF 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.