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
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
PPE Level D kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MTECHSTS
Companies
- Manufacturer
-
MTECHSTS
13-5, Dongmakgolgil 40beongil, Chowol-eup
Gwangju
KOREA, REPUBLIC OF'