Blom-singer Classic Indwelling Voice Prosthesis - Sterile Series (2018-06-22)

Recall Summary Blom-Singer Classic Indwelling Voice Prosthesis devices in the Sterile Series are being recalled in Canada because they do not meet sterility requirements. These devices are used by people who have had their larynx removed to help them speak. The recall affects all units distributed across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-07-05

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d427cc74-e745-47fc-8e14-7f50ffd15102