CanadaArmstrong Medical Limited ventilator circuit for non-invasive ventilation (model AMVC1792-013, all lots) is affected; it can be identified by the product name and model number. The recall was issued because tubing may separate from the purple cuff connector and the instructions for use will be updated to include warnings and user instructions. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Armstrong Medical Limited, Wattstown Business Park, Coleraine, Northern Ireland, United Kingdom, BT52 1BS.
How to identify it
Affected products: Ventilator Circuit For Non-Invasive Ventilation; Lot or serial number: All lots.; Model or catalogue number: AMVC1792-013
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)