Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Covidien LLC Monosof Nonabsorbable Monofilament Nylon Surgical Suture, Novafil Monofilament Polybutester Nonabsorbable Sutures, Sofsilk Nonabsorbable Braided Silk Surgical Suture, Surgipro Ii Surgical Suture, Surgipro Nonabsorbable Monofilament Polypropylene Surgical Suture, Ti-Cron Penetrating Point 1/2 Circle, Ti-Cron Reverse Cutting 1/2 Circle, Ti-Cron Taper Cardiopoint, 300 Series Steel 1/2 Circle, Ti-Cron Taper Cardiopoint, 300 Series Steel 3/8 Circle, Ti-Cron Taper Point 1/2 Circle [Multiple Model or catalogue number] [HKMD No.: 100441, 100442, 110197, 120482, 120483, 160332].
According to Health Canada, the manufacturer has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier breach include infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/medtronic-nonabsorbable-sutures
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Dec 2022