Z-0495-2020 Class II Terminated

Recalled by AMD Medicom Inc. — Lachine, N/A

Recall Details

Product Type
Devices
Report Date
November 27, 2019
Initiation Date
October 11, 2019
Termination Date
September 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 cases (500 units/case)

Product Description

MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

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 Pattern

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.

Code Information

Lot 1917