Product Wiki · Recalls · Health Canada — Medical Devices

Shaver Handpiece Sterilization Tray (2014-05-30) — recall 51933

Health Canada — Medical Devices · Canada · 2014-07-03 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51933
Date of alert
2014-07-03
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: During testing shaver hand piece tray failed Sterrad 100s half cycle testing and did not demonstrate a sterility assurance level of 10-6 for the TPS shaver. It has been determined that the reprocessing guide (P10299 Rev. A) is the non-conforming part of the shaver hand piece tray and the sterilization method with inadequate sterilization validation (Sterrad 100s) needs to be removed as a sterilization option for the TPS small joint shaver.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/shaver-handpiece-sterilization

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