CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) recalled

ConvaTec is recalling DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk), distributed in 13 states. The recall was initiated on 20 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 8G03458, Expiry Jul 2023

Quantity recalled170 packs

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-2614-2021
FDA event ID: 88557
Recalling firm: ConvaTec, Greensboro, NC
Classification: Class II
Status: Ongoing
Recall initiated: 20 Aug 2021
FDA classified: 30 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

20 Aug 2021	Recall initiated by company
30 Sep 2021	Classified by FDA	+41 days
6 Oct 2021	Published in enforcement report	+6 days

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

Reason for recall

Primary packaging labeling may be incorrect.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

Where it was distributed

Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

California Florida Georgia Illinois Maryland Minnesota North Carolina New Jersey New Mexico Ohio Pennsylvania Texas Virginia

Questions about this recall

Is DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) recalled?

Yes. ConvaTec recalled DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) on 20 Aug 2021. The recall is Class II and its status is Ongoing. Recall number Z-2614-2021.

Why was it recalled?

Primary packaging labeling may be incorrect.

Which lots are affected?

Lot Number 8G03458, Expiry Jul 2023

Where was it sold?

Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

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.

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