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Covidien, LP recalls Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of
Recalled May 8, 2024 · FDA recall Z-1697-2024 · Covidien
Hazard
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. · FDA Class II
Units
36 total, OUS distribution only
Sold at
International distribution in the countries of Portugal and Italy.
Description
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.
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(s)
Covidien, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →