RegWardenFDA facility compliance records
Recall

Class II — ConvaTec, Inc

Recalling firmConvaTec
Registered facilityView this company's 6 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonPrimary packaging labeling may be incorrect.
ProductDuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Quantity170 packs
DistributionDistribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA
Initiated2021-08-20
Classified2021-09-30
Recall numberZ-2614-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — ConvaTec, Inc (Z-2614-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88557/

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