Health product recall

Hemashield Gold Knitted Graft

Last updated

Summary

Product
Hemashield Gold Knitted Graft
Issue
Medical devices - Sterility 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
Hemashield Gold Knitted Graft 1424674363 - lot 22L02 M002020851270 M002020851680

Issue

Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility assurance level cannot be guaranteed.

Recall start date: January 23, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Intervascular SAS

Z.I. Athelia 1, La Ciotat, France, 13705

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72634