Rotem Ex-tem Thromboelastometry With Extrinsic Activation (2019-07-19)

Recall Summary Rotem ex-tem thromboelastometry devices with extrinsic activation are being recalled across Canada due to a medical device issue. These devices are used to measure blood clotting properties in medical settings. The recall affects all units distributed throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-08-02

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bcc3bdf0-fa4d-4da8-9c15-d55a5be96dd3