Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA is recalling Surgipro II sutures due to potential sterile packaging defects that could cause biocontamination and infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect may lead to infection and loss of vision, which constitutes significant injury reports under the rubric for a score of 4.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Surgipro II sutures (Model S8698GX) manufactured by Covidien, LP. The recall involves 135,875 units distributed in the United States and numerous international countries. The specific lot number is D5M3438FY, and the UDI-DI is 20612479214716.
The recall is being issued because the product may contain a perforation or tear in the sterile barrier packaging. This defect may result in the biocontamination of the sterile sutures. If used, this contamination may lead to infection, loss of vision if used in ophthalmic procedures, or prolonged surgery.
Healthcare providers and facilities should check their inventory for the affected lot number and stop using these sutures. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- Manufacturer
- Covidien, LP
- Affected units
- 135,875
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 (1)
- S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Distribution
Distributed nationwide across the United States.
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