Custom-pak Ophthalmic Surgery Procedure Pack (2017-10-10)

Summary Custom-Pak Ophthalmic Surgery Procedure Packs are being recalled across Canada because they are classified as medical devices that were not properly approved or licensed for sale. The recall affects all Custom-Pak Ophthalmic Surgery Procedure Packs that were distributed throughout 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

2017-10-20

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/08ae2da8-c1ba-4a41-9896-31648edc9f07