Health product recall

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 issue
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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