Custom Procedure Kit - Stroke (2021-02-08)

Recall Summary A Custom Procedure Kit for Stroke treatment is being recalled in Canada because it is classified as a medical device that does not meet regulatory requirements. The recall affects all units of this product that were distributed across Canada. This is a Class I recall, which is the most serious classification.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-08-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/78eef566-4b72-461d-bf8b-4234f2505f68