Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
Covidien is recalling Dermalon 4-0 sutures because sterile barrier packaging may be perforated or torn, risking biocontamination and infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury, including loss of vision and infection, which meets the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for Dermalon 4-0 Blue 75cm sutures manufactured by Covidien, LP. The recall affects specific lots identified by UDI-DI 10884521070912, 20884521070919, and 20884521071060, with lot numbers D6A3020FY and D6A2861FY. A total of 135,875 units were distributed nationwide in the United States and to numerous international markets.
The recall was initiated because the sterile barrier packaging for these sutures may contain a perforation or tear. This defect could result in the biocontamination of the sterile sutures. If used, the contamination may lead to infection, loss of vision if utilized in ophthalmic procedures, or prolonged surgery.
Healthcare providers and facilities that have received these specific lots of Dermalon sutures should stop using them immediately and contact the recalling firm for instructions on return or disposal. Consumers should not use these medical devices at home.
The recalled product
- Product
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Sutures
- Affected units
- 135,875
Distribution
Distributed nationwide across the United States.
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