Covidien, LP: Sofsilk Braided Silk Sutures Recalled for Reduced Strength and Injury Risk

Agency Publication Date: April 29, 2024

Summary

Covidien, LP is recalling 36 units of Sofsilk Braided Silk sutures because one lot was exposed to too many sterilization cycles. These nonabsorbable surgical sutures, used for soft tissue approximation and ligation, may have decreased strength over time, causing them to fail during or after surgery. This recall specifically affects Product Number S-2782K from lot D2F2101RY, which was distributed internationally to Portugal and Italy.

Risk

The excess sterilization cycles can weaken the suture material, leading to it breaking during use. This can result in serious complications such as wounds reopening (dehiscence), severe bleeding (hemorrhage), tissue breakdown, internal infections like peritonitis, or even vision loss if used in eye surgeries.

What You Should Do

Identify your product by checking the packaging for Sofsilk Braided Silk sutures, Product Number S-2782K, with UDI-DI 20884521086422 and Lot Number D2F2101RY.
Immediately stop using any sutures from the affected lot and set them aside to prevent accidental surgical use.
Contact your healthcare provider or hospital administration to determine if this product was used in any recent procedures and for guidance on next steps.
Contact the manufacturer, Covidien, LP (a Medtronic company), to report the possession of affected units and to receive instructions on returning the product and obtaining a potential refund.
For additional information or to report any adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Sofsilk Braided Silk sutures, Product Number S-2782K

Model / REF:

S-2782K

UDI-DI 20884521086422

Lot Numbers:

D2F2101RY

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94351

Status: Active

Manufacturer: Covidien, LP

Sold By: International distributors

Manufactured In: United States

Units Affected: 36 total, OUS distribution only

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your product by checking the packaging for Sofsilk Braided Silk sutures, Product Number S-2782K, with UDI-DI 20884521086422 and Lot Number D2F2101RY.

Immediately stop using any sutures from the affected lot and set them aside to prevent accidental surgical use.

Contact your healthcare provider or hospital administration to determine if this product was used in any recent procedures and for guidance on next steps.

Contact the manufacturer, Covidien, LP (a Medtronic company), to report the possession of affected units and to receive instructions on returning the product and obtaining a potential refund.

For additional information or to report any adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.