Health product recall

Medicom SafeMask Premier Elite & Premier Plus (2019-10-09)

Starting date:
October 9, 2019
Posting date:
November 1, 2019
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-71461



Last updated: 2019-11-01

Affected Products

  1. Medicom SafeMask Premier Plus
  2. Medicom SafeMask Premier Elite

Reason

Some level 2 masks (code 2040) may have been packed in some level 3 mask boxes (code 2042). The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.

Affected products

A. Medicom SafeMask Premier Plus

Lot or serial number

1917

Model or catalog number

2040

Companies
Manufacturer

AMD Medicom Inc.

1200 55th Avenue

Montréal

H8T 3J8

Quebec

CANADA


B. Medicom SafeMask Premier Elite

Lot or serial number

1917

Model or catalog number

2042

Product UPC

0

Companies
Manufacturer

AMD Medicom Inc.

1200 55th Avenue

Montréal

H8T 3J8

Quebec

CANADA