FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1697-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1697-2024
- Event ID
- 94351
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2024
- Initiation Date
- January 25, 2024
- Classification Date
- April 29, 2024
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
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.
Reason
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.
Code Info
UDI-DI 20884521086422 Lot D2F2101RY
Distribution
International distribution in the countries of Portugal and Italy.
Quantity
36 total, OUS distribution only