Medical Device Recall: 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.
Covidien, LP · January 25, 2024
Reason for Recall
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
Distribution
International distribution in the countries of Portugal and Italy.
States Affected
IN
Quantity Affected
36 total, OUS distribution only
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1697-2024
Status: ongoing
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