PPE Level D kit (2020-07-23)

Starting date:

July 23, 2020

Posting date:

August 28, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73761

Last updated:
2020-08-28

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  Reason
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  Affected products

Affected Products

PPE Level D kit

Reason

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.

Affected products