Health Canada — Medical Devices · Canada · 2017-06-13 · Type II
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Reported risk: Argon Medical is conducting a recall to notify customers of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. The risk is limited to any products packaged on December 15, 2016. The expected rate of defect is mall and the type of defect is visible with the naked eye. The product literature warns the user to not use this product if the packaging is opened or damaged.
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