Product Wiki · Recalls · Health Canada — Medical Devices

Medtronic Nonabsorbable Sutures — recall 72355

Health Canada — Medical Devices · Canada · 2022-12-13 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
72355
Date of alert
2022-12-13
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: Medtronic 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. Through 01-November-2022, Medtronic has received no complaints of packaging integrity defects or reports of serious patient injury related to this issue. There are no additional patient management recommendations for patients where potentially affected non-absorbable sutures in the scope of this recall were used during a procedure. These patients should continue to be monitored in accordance with the registered medical facility's standard care protocols with consideration to the specific use. Recall start date: December 1, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/medtronic-nonabsorbable-suture

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