Recall Monitor
Health Products

Ventilator Circuit For Non-Invasive Ventilation

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Ventilator Circuit For Non-Invasive Ventilation
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Ventilator Circuit For Non-Invasive VentilationAll lots.AMVC1792-013

Issue

Armstrong Medical LTD are submitted this FSCA report in relation to the recall and field safety notice for a device correction to mitigate the risk of tubing separation from purple cuff connector for affected devices listed in the FSN. An update to the IFU of affected devices is to be issued to include warnings and instructions for the user.

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