Quadrox-i Neonatal Oxygenator With Integrated Hardshell Reservoir (2021-05-12)

QUADROX-I Neonatal Oxygenator Recall The QUADROX-I Neonatal Oxygenator with Integrated Hardshell Reservoir is being recalled across Canada. The device may have cracks in the hardshell reservoir that could allow air to enter the blood circuit during use. This recall affects hospitals and medical facilities that use this oxygenator for newborn patients requiring heart-lung support.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-05-20

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bd52ae9c-04e5-4de9-8b73-eca6e48faddc