FDAClass IIDecember 14, 2022

Dover Closed Urethral Tray with Hydrogel Coated Red recall

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…

Why was Dover Closed Urethral Tray with Hydrogel Coated Red recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

Product
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…
Recalling firm
Cardinal Health
Quantity
N/A
Distribution
Nationwide
Recall date
December 14, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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