BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0107-2021 · Reported October 21, 2020

    Enforcement

    Recall Number
    Z-0107-2021
    Event ID
    86380
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 21, 2020
    Initiation Date
    July 21, 2020
    Classification Date
    October 14, 2020
    Address
    6725 Nw 36th St # 600, N/A, Miami, FL, 33166, United States

    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.

    Code Info

    Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01

    Distribution

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

    Quantity

    18,500,000 Masks