BEUDAMED
    FDA Recall Open, Classified

    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

    Recall: Z-0107-2021 · Initiated July 21, 2020

    Recall

    Recall Number
    Z-0107-2021
    Event Number
    86380
    Firm
    BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
    FEI Number
    3016691009
    Product Code
    QKR
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    July 21, 2020
    Address
    6725 Nw 36th St, # 600, Miami, FL, 33166

    Description

    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

    Reason

    Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

    Action

    During conference calls on July 23 and July 24 with customers, we discussed quarantining the masks. The masks have been quarantined since. Ezywipe has agreed that it will quarantine the masks if they are sent back from the customer.

    Distribution

    US Nationwide distribution including in the states of CA and OH.

    Quantity

    18,500,000 Masks