BEUDAMED
    FDA Enforcement Class II Terminated

    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    Recall: Z-2815-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2815-2020
    Event ID
    86034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Whirlpool Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2020
    Initiation Date
    July 2, 2020
    Classification Date
    August 14, 2020
    Termination Date
    June 25, 2021
    Address
    World Headquarters, N/A, Benton Harbor, MI, 49022, United States

    Description

    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    Reason

    The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.

    Code Info

    Lot code: JX20 (or week #20 of 2020)

    Distribution

    The products were distributed to the following US states: MI.

    Quantity

    528 units