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Sofsilk™ braided silk sutures and ti-cron™ coated braided polyester sutures
Official notice
31 Jan 2024
An official Health Canada notice concerns Sofsilk™ braided silk sutures and ti-cron™ coated braided polyester sutures. Specific lots of the Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. The affected lots were distributed between May 2022 and November 2023. The extra gamma levels or additional EO cycle have the potential to decrease the strength of these sutures over time. Recall Start Date: January 25, 2024 Published 2024-01-31.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74963
Official notice
2024-01-31
The hazard
The hazard
Specific lots of the Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures were sterilized with gamma doses that exceeded the range approved or were exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. The affected lots were distributed between May 2022 and November 2023. The extra gamma levels or additional EO cycle have the potential to decrease the strength of these sutures over time. Recall Start Date: January 25, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Covidien, Sofsilk™ Braided Silk Sutures And Ti-cron™ Coated Braided Polyester Sutures.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
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Source tier
Documents, notices & source
See the official notice and source documents for full details.
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