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U.S. Department of Health and Human Services

Class 2 Device Recall DuoDERM

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 Class 2 Device Recall DuoDERMsee related information
Date Initiated by FirmAugust 09, 2021
Create DateSeptember 23, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2519-2021
Recall Event ID 88460
Product Classification Dressing, wound, occlusive - Product Code NAD
ProductDuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Code Information ICC 187660 - Lots 9B02984Y, 9G04308, 9K05775, 9L00556, 0A03460, and 9A04124Y ICC 187957 - Lots 9J02859, 9H02226, 9H04865, 9L02456 ICC 187955 - Lots 9L01731, 9L04890, 9K02656, 9H01234, 9M01779, and 9H00183
FEI Number 3011987967
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7815 National Service Rd Ste 600
Greensboro NC 27409-9403
For Additional Information Contact
336-547-3730
Manufacturer Reason
for Recall		There is a potential for open seals which can compromise sterility.
FDA Determined
Cause 2		Process control
ActionCustomer notification was made via email and via UPS letter. Distributors are asked to stop distributing and quarantine all recalled lots. All customers are notified that a Recall Response Form is to be completed and returned to the recalling firm. All impacted product is to be returned via third party Sedgwick, Indianapolis, IN. If product was further distributed, the customer shall forward the recall notification letter and ask subaccounts to follow the recall instructions.
Quantity in Commerce2,734,830 units
DistributionInternational distribution to the countries of Argentina, Aruba, Australia, Bonaire, Brazil, Canada, Chile, , Colombia, Costa Rica, Curaco, Dominican Republic, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Indonesia, Iran, Malaysia, Mexico, Myanmar, Nicaragua, New Zealand, Panama, Peru, , Pakistan, Paraguay, Qatar, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, Uruguay, USA and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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