ConvaTec DuoDERM wound dressings recalled for potential sterility compromise
ConvaTec is recalling DuoDERM CGF and Extra Thin dressings due to potential open seals that could compromise sterility. Approximately 2.7 million units were distributed internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a sterile medical device with potential for compromised sterility. No illnesses or injuries have been reported in the source material, making this a risk-of-harm product without reported injury.
Plain-English summary
ConvaTec, Inc is recalling specific lot numbers of DuoDERM CGF Dressing (10x10 cm) and DuoDERM Extra Thin Dressing (15x15 cm and 10x10 cm) due to potential open seals. Approximately 2.7 million units have been affected.
The concern is that open seals compromise the sterility of these medical dressings. Sterile wound care is essential to prevent infection when dressings are applied to wounds or areas of compromised skin.
These products were distributed internationally to 37 countries including the United States, Canada, Australia, and many others. The recall applies to specific lot numbers identified by ConvaTec and the FDA.
Consumers in possession of affected DuoDERM dressings from the recalled lot numbers should discontinue use and contact ConvaTec or their healthcare provider for replacement or guidance.
The recalled product
- Product
- DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressings
- Affected units
- 2,734,830
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
Distribution scope not specified by the agency.
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