AMD Medicom Inc. recalls MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

Recall date

October 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0494-2020

FDA classification

Class II

Brand / firm

AMD Medicom Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040