Custom Pack With Softline, Quadrox-i Neonatal Oxygenator With Integrated Hardshell Reservoir (2019-05-12)

Recall Summary Health Canada is recalling Custom Pack with Softline, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir medical devices across Canada due to a safety issue. The recall is classified as Class I, indicating a serious potential health risk. This recall affects neonatal (newborn) oxygenation equipment that was distributed throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-05-24

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e003d6b3-9d95-4813-b35a-187d3aa5a131