FDA recall Z-1971-2019

Product

ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.

Reason for recall

Potential for failed stability antimicrobial effectiveness testing.

Distribution

US nationwide distribution including the states of AZ, CA, CT, FL, IL, MA, MI, MN, NC, NJ, NY, OH, PA, RI, TX, TN, VT, WV. Distributed Internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia and Canada.

Key facts

Status

Terminated

Initiation date

2019-06-19

Report date

2019-07-24

Termination date

2020-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1971-2019