Product Wiki · Recalls · Health Canada — Medical Devices

Various Paragon Oxygenators (2017-06-07) — recall 57161

Health Canada — Medical Devices · Canada · 2017-10-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57161
Date of alert
2017-10-06
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: Due to the coating used on the Paragon Oxygenators, the classification originally assigned to the oxygenators (class II), is to be amended to a class IV. Until the class IV application has been processed, manufacturer will voluntarily cease sale of the Paragon Oxygenators. This does not affect products that have already been sold to customers
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/various-paragon-oxygenators-20

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