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Recall Observatory FDA recall evidence

Device product

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

Z-2815-2020

July 02, 2020

Class II

Product summary

Firm
Whirlpool Corporation
Event
Event 86034
Status
Terminated
Classification
Class II
Quantity
528 units
Official record key
device-enforcement:Z-2815-2020

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.