Medical Device Recalls Health Canada

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Recalls - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls.html

Recalls - Canada.ca Recalls The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, …

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

Use the Medical Device Recall Reporting Form - Initial (FRM-0360) to complete your initial recall report. Submit a section 65 final report to your nearest …

Advisories, Warnings and Recalls – Drugs and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/advisories-warnings-recalls.html

Health Canada believes that staying informed can help you stay healthy. To this end, the Department posts safety alerts, public health advisories, press releases and other notices …

Adverse reactions, medical device incidents and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html

Medical Device Respirator recalls - Recalls and safety …

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73137a-eng.php?from=groupmessage&isappinstalled=0

In Canada, re-labelling of a medical device that fails to conform to claims relating to its effectiveness is considered a recall in accordance with the Medical …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, …

Incident reporting for medical devices: Guidance document

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

As is defined in section 1 of the Regulations, in respect of a medical device that has been sold, recall means any action taken by the manufacturer, importer or distributor of the device to recall or …

Health Canada Guidance on Recalls: Basics | RegDesk

https://www.regdesk.co/health-canada-guidance-on-recalls-basics/

Jul 22, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is …

Find recalls, advisories and safety alerts - Canada.ca

https://recalls-rappels.canada.ca/en

Latest recalls and safety alerts Health Canada warns that Dr. Crafty branded epoxy kits may pose an injury hazard due to improper labelling Alert Consumer product advisory | …

Transport Strut Hoffmann Lrf - Canada.ca

https://recalls-rappels.canada.ca/en/alert-recall/transport-strut-hoffmann-lrf

Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the …

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