FDA-Device2024-05-08Class II
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
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.
Sold states
International distribution in the countries of Portugal and Italy.
Affected count
36 total, OUS distribution only
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2024Don't want to check this manually?
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