Sofsilk Braided Silk sutures recall
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use…
Why was Sofsilk Braided Silk sutures recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 20884521086422 Lot D2F2101RY
- Product
- Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use…
- Recalling firm
- Covidien, LP
- Quantity
- 36 total, OUS distribution only
- Distribution
- International distribution in the countries of Portugal and Italy.
- Recall date
- May 8, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)