ALLTA KN95 Mask (2020-05-20)
- Starting date:
- May 20, 2020
- Posting date:
- June 12, 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-73309
Last updated: 2020-06-15
Affected Products
ALLTA KN95 Mask
Reason
KN95 respirators failed to meet 95% filtration specification. Out of 10 samples tested by NIOSH, 3 samples tested 93.61%, 94.54% and 94.91% effectiveness which is lower than 95% required for a respirator.
Affected products
ALLTA KN95 Mask
Lot or serial number
Not applicable.
Model or catalog number
ALLTA KN95 Masks
Companies
- Manufacturer
-
ZHEJIANG ALLTA INDUSTRY CO. LTD
#2112, NANBAIXIANG SECTION 104 NATIONAL ROAD, NANBAIXIANG SUB-DISTRICT OUHAI DISTRICT
Wenghou
CHINA