Device product
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
Z-2815-2020
Product summary
- 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
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.