Recall Z-0494-2020— AMD Medicom Inc.

Name: FDA recall Z-0494-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-11

Class II · Terminated

Class II FDA medical device recall by AMD Medicom Inc., initiated 2019-10-11, terminated 2021-09-14. It names one FDA 510(k) clearance: K051291. Product: MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040. Reason: 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..

Recalling firm: AMD Medicom Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Terminated: 2021-09-14
Firm location: Lachine, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K051291 — NON-STERILE SURGICAL MASKA.R. Medicom, Inc.·cleared 2005-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.