Product Wiki · Recalls · Health Canada — Medical Devices

Artas Disposable Kit (2013-10-14) — recall 50995

Health Canada — Medical Devices · Canada · 2013-12-17 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
50995
Date of alert
2013-12-17
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: There is a discoloration on the tensioner pins that was observed prior to performing the Artas procedure. This discoloration has been identified as a compound of iron and chlorine and found to be a remnant of the cleaning process used on the stainless steel (SS303) tensioner pins by the pin manufacturer. Action has been taken to ensure that replacement product uses pins that have been properly cleaned and all potentially affected product in the field are to be returned and replaced.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/artas-disposable-kit-2013-10-1

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