Class 2 Device Recall Ezycare Face Masks

• Date Initiated by Firm: July 21, 2020
• Create Date: October 14, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0107-2021
• Recall Event ID: 86380
• Product Classification: Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance - Product Code QKR
• Product: Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
• Code Information: Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
• Recalling Firm/ Manufacturer: BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA; 6725 Nw 36th St # 600; Miami FL 33166
• Manufacturer Reason for Recall: Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
• FDA Determined Cause: No Marketing Application
• Action: During conference calls on July 23 and July 24 with customers, we discussed quarantining the masks. The masks have been quarantined since. Ezywipe has agreed that it will quarantine the masks if they are sent back from the customer.
• Quantity in Commerce: 18,500,000 Masks
• Distribution: US Nationwide distribution including in the states of CA and OH.
• 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.