Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2815-2020Class II

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

Whirlpool Corporation / initiated 2020-07-02 / Terminated / root cause: manufacturing process

Whirlpool Corporation began a recall of PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2815-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Whirlpool Corporation
Product
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
Product code
NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
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.
Root cause tag
manufacturing process
FDA root cause
Manufacturing material removal
Action
Customers were contacted via email/telephone beginning 6/18/20. Rework was conducted in-house at the customer facilities.
Quantity in commerce
528 units
Distribution
The products were distributed to the following US states: MI.
Product codes and lots
Lot code: JX20 (or week #20 of 2020)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2815-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2815-2020Class IITerminatedVoluntary: Firm initiated