Quadrox-i Neonatal Oxygenator, Quadrox-i Neonatal Oxygenator With Integrated Hardshell Reservoir, And Custom Pack With Softline (2018-10-16)

Recall Summary Quadrox-i Neonatal Oxygenators and related products are being recalled in Canada due to a device defect. These oxygenators are medical equipment used in neonatal care to help newborns breathe. The recall affects all units distributed across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-10-26

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/19e36b98-2f55-450a-b6cd-ccb891edad39