Sofsilk Braided Silk sutures recalled due to excess sterilization
One lot of Sofsilk Braided Silk sutures (Product Number S-2782K) was exposed to more sterilization cycles than approved, which may reduce tensile strength and increase risks of wound complications and infections during surgery.
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 3/5 (High).
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: FDA Class II recall with no reported illnesses or injuries. Although the potential harms are serious (hemorrhage, peritonitis, infection), the source indicates these are theoretical risks using language such as 'may decrease' tensile strength and 'could result in' complications.
Plain-English summary
Covidien, LP is recalling one lot of Sofsilk Braided Silk sutures (Product Number S-2782K) because the product was exposed to more Ethylene Oxide sterilization cycles than approved. This excess sterilization may reduce the sutures' tensile strength over time.
The recalled sutures are nonabsorbable, sterile surgical sutures composed of natural silk fibers. They are used for soft tissue approximation and ligation. One lot (D2F2101RY) containing 36 units was distributed to Portugal and Italy only.
Reduced tensile strength may result in wound dehiscence, hemorrhage, blood loss, tissue breakdown, peritonitis, infection, and vision loss (in eye surgery). These complications could extend the surgical procedure duration and require additional medical care.
The recalled product
- Product
- Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
- Manufacturer
- Covidien, LP
- Affected units
- 36
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)
- UDI-DI 20884521086422 Lot D2F2101RY
Distribution
Distribution scope not specified by the agency.
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