FDA recall Z-0494-2020

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-10-11

Report date

2019-11-27

Termination date

2021-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lachine, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2020