Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures
Brand(s)
Last updated
Summary
Product
Sofsilk™ Braided Silk sutures and Ti-Cron™ Coated Braided Polyester Sutures
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ti-Cron Reverse Cutting 3/8 Circle | D2C3250FRY | 8886307051 |
| Ti-Cron Taper Cardiopoint, 300 Series Steel 1/2 Circle | D1M2840RY D2C0774RY | 8886308731 8886318541 |
| Sofsilk Nonabsorbable Braided Silk Surgical Suture | D2D0262RY D2E1492RY D2E1210RY D2E1375RY D1K1916FRY D2J0691RY D1M0153RY D2E1491RY D2E2348RY | SS675 S246 S1750K S318 S605 S608 S1172 S1789K S243 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Covidien LLC
15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74963
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