Heater-cooler Units

Recall Summary LivaNova heater-cooler units used in cardiac surgery are being recalled because they may become contaminated with bacteria during use, which could potentially cause serious infections in patients. The recall affects heater-cooler units distributed across Canada that are used in operating rooms to regulate patient temperature during heart surgery. Healthcare facilities using these units have been notified of the recall.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-09-09

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/78353581-5e39-4320-a1e8-7687600a6641