Product Wiki · Recalls · Health Canada — Medical Devices

Disposable Hyperinflation System (2019-07-24) — recall 59992

Health Canada — Medical Devices · Canada · 2019-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59992
Date of alert
2019-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Hyperinflation system has been packaged with the manometer, which did not include the shelf life of the manometer. The root cause was determined to be that the shelf life of the manometer was moved from ifu to pouch labeling. During assembly, manometer is opened from the pouch and attached to the hyperinflation bag. However, accompanying packaging (plastic pouch) for the manometer is discarded. This results in a loss of shelf life information for the finished good.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/disposable-hyperinflation-syst

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