Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-3024-2020Class II

JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces

Office Depot Inc / initiated 2020-07-27 / Open, Classified

Office Depot Inc began a recall of JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces on . FDA classified it as Class II and gives the reason as "Test results revealed that the KN95 masks failed to filter greater than 95% of particulates". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-3024-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Office Depot Inc
Product
JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces
Product code
NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Reason for recall
Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.
FDA root cause
Other
Action
The firm notified its consignees be email on 07/29/2020. The notice indicated that the product was tested and did not live up to expectations. The firm is offering a replacement of the product.
Quantity in commerce
25,360 masks
Distribution
nationwide
Product codes and lots
SKU 4555098 & 8510447

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3024-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-3024-2020Class IIOngoingVoluntary: Firm initiated