Recall Z-1697-2024
Covidien, LP · initiated January 25, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI-DI 20884521086422 Lot D2F2101RY
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.
FDA-determined cause: Process control
Action taken
On January 25, 2024, Medtronic issued an expansion to their earlier recall for sutures (RES 93768) concerning gamma sterilization. As part of that expansion, there was an additional lot of product which was exposed to more than the approved number of EO sterilization cycles, which is covered in this recall, RES 94351. The issue was communicated to affected consignees via letters. Consignees are asked to return any affected product they may have, forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred.
Details
- Recall number
- Z-1697-2024
- Initiated
- January 25, 2024
- Posted by FDA
- April 29, 2024
- Product code
- GAP – Suture, Nonabsorbable, Silk
- Quantity
- 36 total, OUS distribution only
- Distribution
- International distribution in the countries of Portugal and Italy.
- Recalling firm
- Covidien, LP, North Haven, CT