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U.S. Department of Health and Human Services

Class 2 Device Recall JINYINSHAN, KN95 PROTECTIVE MASK

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  Class 2 Device Recall JINYINSHAN, KN95 PROTECTIVE MASK see related information
Date Initiated by Firm July 27, 2020
Create Date September 28, 2020
Recall Status1 Open3, Classified
Recall Number Z-3024-2020
Recall Event ID 86241
Product Classification Respirator, n95, for use by the general public in public health medical emergencies - Product Code NZJ
Product JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces
Code Information SKU 4555098 & 8510447
Recalling Firm/
Manufacturer		 Office Depot Inc
6600 N Military Trl # N203r
Boca Raton FL 33496-2434
For Additional Information Contact Sourcing Partner
800-949-9974
Manufacturer Reason
for Recall		 Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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