DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Ex
Summary
The FDA issued a Class II for DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 1 by ConvaTec, Inc. Reason: There is a potential for open seals which can compromise sterility..
Details
Source
Device Recall
External ID
Z-2519-2021
Action Date
2021-09-29
Status
Ongoing
Category
device
Product Description
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Lot/Code Info: 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
Quantity Affected: 2,734,830 units
Reason for Recall
There is a potential for open seals which can compromise sterility.
Distribution
International 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-09
Company
Greensboro, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConvaTec, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConvaTec, Inc have FDA actions?
ConvaTec, Inc has 18 FDA actions in our database, including 16 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2519-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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