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Recall Observatory FDA recall evidence

Device product

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

Z-2614-2021

August 20, 2021

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 88557
Status
Ongoing
Classification
Class II
Quantity
170 packs
Official record key
device-enforcement:Z-2614-2021

Official wording

Reason: Primary packaging labeling may be incorrect.

Code information: Lot Number 8G03458, Expiry Jul 2023

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling may be incorrect

Field note

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