Product Wiki · Recalls · Health Canada — Medical Devices

Aerial Cushion (2014-02-13) — recall 51469

Health Canada — Medical Devices · Canada · 2014-04-14 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51469
Date of alert
2014-04-14
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Recent routine internal fire testing to test flammability after multiple washings of the device (N=5) of the whole cushion (cover and foam) in water after 40 degrees celsius, revealed a potential risk of flammability from the product (the "testing failure"). This testing failure contradicts the information contained in the company's instructions for use wherein it states: "hand wash all foam breathair components in warm water at 40 degrees celsius using a standard mild detergent. Do not use fabric softner. Rinse well."
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aerial-cushion-2014-02-13

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