Product Wiki · Recalls · Health Canada — Medical Devices

PPE Level D kit (2020-07-23) — recall 61543

Health Canada — Medical Devices · Canada · 2020-08-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61543
Date of alert
2020-08-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The buyer, PHSA (Provincial Health Services Authority) inspected PPE products in March 2020 and with their assessment results, PPE kit was qualified to use so we received the purchase order and fulfilled the order for PHSA in April. However, we realized the gloves require a device license other than MDEL license. The gloves were part of the kit so the kit itself is considered as class II medical device, which should be licensed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ppe-level-kit-2020-07-23

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