CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report

Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter Product recalled

Cardinal Health is recalling Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter, distributed nationwide in the US. The recall was initiated on 1 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0356-2023
FDA event ID: 91087
Recalling firm: Cardinal Health, Mansfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Nov 2022
FDA classified: 2 Dec 2022
Reported: 14 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

1 Nov 2022	Recall initiated by company
2 Dec 2022	Classified by FDA	+31 days
14 Dec 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 91087

Reported	Class	Recall	Company	Reason	Where
14 Dec 2022	CLASS II	Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled	Cardinal Health	Foreign Material	Nationwide
14 Dec 2022	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled	Cardinal Health	Other	Nationwide
14 Dec 2022	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter Product recalled	Cardinal Health	Other	Nationwide
14 Dec 2022	CLASS II	Dover Closed Urethral Tray with Vinyl Catheter/Ch Catheter recalled	Cardinal Health	Other	Nationwide
14 Dec 2022	CLASS II	Dover Closed Urethral Tray with Hydrogel Coated Red Rubber recalled	Cardinal Health	Foreign Material	Nationwide

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