FDA-Device2019-11-27Class II
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
AMD Medicom Inc.
Hazard
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
Sold states
The products were distributed tot he following US states: CA, FL, IA, IN, MD, MI, NV, NY, PA, SC, TN, TX, and WA. The products were distributed to the following foreign countries: Canada.
Affected count
756 cases (500 units/case)
Manufactured in
1200 55e Ave, N/A, Lachine, N/A, Canada
Products
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2020Don't want to check this manually?
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