Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Cook, Inc. Blue Rhino G2 Multi Percutaneous Tracheostomy Introducer Set and Tray [Model or catalog number: C-PTIS-100-HC-G-EU-FLEX8.5, C-PTISYJ-100-HC-G-EU-FLEX8.5, C-PTIS-100-HC-G-EU-FLEX7.5; Lot or serial Number: More than 20 Lot numbers] [HKMD No.: 220320].
According to Health Canada, Medtronic is recalling the tracheostomy tubes that are supplied with these devices, following reports from customers that the device connector in some instances is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. Therefore, Cook is also recalling these products.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/blue-rhino-g2-multi-percutaneous-tracheostomy-introducer-set-and-tray
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Apr 2023