Single Patient Use Lead Set (2019-09-03)

Recall Summary A Single Patient Use Lead Set has been recalled across Canada due to issues with the medical device. This is classified as a Class I recall, which indicates a serious safety concern. The recall affects all units distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-10-03

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a6b245db-b04e-4590-991b-e7fa99fca9ed