Capiox Fx25 Hollow Fiber Oxygenator With Integrated Arterial Filter

Recall Summary The Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter is being recalled across Canada due to a performance issue. This device is used during heart-lung bypass procedures to oxygenate blood during cardiac surgery. The recall is classified as Class I, meaning there is a reasonable probability that use of the device could cause serious injury or death.

Product

Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2023-03-09

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/af790fa0-cd91-44a1-bed3-3bc1a8987b5e