Device product
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Z-0107-2021
Product summary
- Event
- Event 86380
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,500,000 Masks
- Official record key
device-enforcement:Z-0107-2021
Official wording
Reason: Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Code information: Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
Distribution pattern: US Nationwide distribution including in the states of CA and OH.
Derived failure modes
-
Unknown
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.