Gore Molding And Occlusion Balloon Catheter (2021-07-09)

Recall Summary W.L. Gore & Associates is recalling certain Gore Molding and Occlusion Balloon Catheter devices across Canada because they may not function as intended due to a manufacturing defect. The affected devices were distributed to hospitals and medical facilities nationwide. This is classified as a Class I recall, indicating a serious potential health risk.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-07-20

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/7d3c5aa4-3d6c-4c92-8d93-1bec72f75db3