Fabian Hfo (2021-07-26)

Summary Fabian HFO devices have been recalled across Canada due to a medical device safety issue. The recall is classified as Class I, indicating a serious potential health concern. The recall affects all Fabian HFO units distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-08-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a1103212-6a5f-4edc-a6b6-62d2537b39c5