Z-0107-2021 Class II Ongoing
FDA device recall Z-0107-2021 was initiated by BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA on July 21, 2020 and is designated Class II. Reason for recall: Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks. The recall status is ongoing. Affected quantity: 18,500,000 Masks.
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2020
- Initiation Date
- July 21, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,500,000 Masks
Product Description
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Reason for Recall
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Distribution Pattern
US Nationwide distribution including in the states of CA and OH.
Code Information
Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01