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Recall Observatory FDA recall evidence

Device product

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

Z-0494-2020

October 11, 2019

Class II

Product summary

Firm
AMD Medicom Inc.
Event
Event 84118
Status
Terminated
Classification
Class II
Quantity
756 cases (500 units/case)
Official record key
device-enforcement:Z-0494-2020

Official wording

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.

Code information: Lot 1917

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.