Class 2 Device Recall JINYINSHAN, KN95 PROTECTIVE MASK

• Date Initiated by Firm: July 27, 2020
• Create Date: September 28, 2020
• Recall Status: Open, 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
• FEI Number: 3000122585
• 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: 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.