Wound dressings recalled because foreign matter may be on the product
ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.
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: Scored 3 under the risk-of-harm criterion: foreign matter on a dressing applied to an open wound creates a contamination risk, and no injuries are reported.
Plain-English summary
DuoDERM Extra Thin dressings, highly flexible control gel formula dressings designed for dry to lightly exudating wounds and particularly suited to areas subject to friction, are being recalled.
The wound dressing may have foreign matter on the product.
The recall covers 80,980 units carrying UDI-DI 768455150922, from lot 3L04808. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record states the presence of foreign matter and reports no injuries. Facilities holding the affected lot should quarantine it and follow ConvaTec's instructions.
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
- contamination
- wound-care
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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