Z-2815-2020 Class II Terminated

Recalled by Whirlpool Corporation — Benton Harbor, MI

FDA device recall Z-2815-2020 was initiated by Whirlpool Corporation on July 2, 2020 and is designated Class II. Reason for recall: 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 a… The recall status is terminated (terminated June 25, 2021). Affected quantity: 528 units.

Recall Details

Product Type
Devices
Report Date
August 26, 2020
Initiation Date
July 2, 2020
Termination Date
June 25, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
528 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

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