Official recall record

Medline Packs with Sofsilk™ Braided Silk Sutures and Ti-Cron™ Coated Braided Polyester Suture

Health Canada — Medical Devices · 2024-02-07 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2024-02-07
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

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 devices were distributed as part of Medline packs between Sep 2022 and January 2024. The extra gamma levels or additional ethylene oxide (EO) cycle have the potential to decrease the strength of these sutures over time. Recall start date: January 19, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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