FDA recall Z-0107-2021

BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA · Class II · device

Product

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

US Nationwide distribution including in the states of CA and OH.

Key facts

Status
Ongoing
Initiation date
2020-07-21
Report date
2020-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2021