DuoDERM Extra Thin wound dressings recalled for foreign matter
ConvaTec is recalling DuoDERM Extra Thin wound dressings (80,980 units) due to potential foreign matter on the product. The recall affects products distributed nationwide.
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 risk-of-harm medical device recall with no reported illnesses or injuries. Foreign matter on wound dressings used on open wounds poses potential infection and tissue damage risks, matching the Score 3 criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc. is recalling DuoDERM Extra Thin dressings due to the potential presence of foreign matter on the product. DuoDERM Extra Thin dressings are flexible, control gel formula wound dressings designed for use on dry to lightly exudating wounds, particularly in areas subject to friction such as elbows and heels.
The recall affects approximately 80,980 units with lot number 3L04808 that have been distributed nationwide across all U.S. states. The presence of foreign matter on the dressing may pose a risk to wound healing and patient safety.
Consumers or healthcare providers who have this product should stop using it immediately. For questions or product replacement instructions, contact ConvaTec, Inc. or the FDA.
The recalled product
- Product
- DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- foreign-matter
- product-defect
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 (2)
- UDI-DI: 768455150922
- Lot: 3L04808
Distribution
Distributed nationwide across the United States.
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