Recall Z-2815-2020— Whirlpool Corporation
Class II · Terminated
Class II FDA medical device recall by Whirlpool Corporation, initiated 2020-07-02, terminated 2021-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Whirlpool Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-02
- Terminated
- 2021-06-25
- Firm location
- Benton Harbor, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.