BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2815-2020 · Initiated July 2, 2020

    Recall

    Recall Number
    Z-2815-2020
    Event Number
    86034
    Firm
    Whirlpool Corporation World Headquarters Benton
    FEI Number
    1826917
    Product Code
    NZJ
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    July 2, 2020
    Terminated
    June 25, 2021
    Address
    Harbor, MI, 49022

    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.

    Action

    Customers were contacted via email/telephone beginning 6/18/20. Rework was conducted in-house at the customer facilities.

    Distribution

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

    Quantity

    528 units