Medical device recalls Moderate risk

Whirlpool Corporation recalls PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

Recall date
July 2, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2815-2020
FDA classification
Class II
Brand / firm
Whirlpool Corporation
Sold / distributed
The products were distributed to the following US states: MI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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