PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 24, 2019 Initiated: June 19, 2019 #Z-1971-2019

Product Description

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

Reason for Recall

Potential for failed stability antimicrobial effectiveness testing.

Details

Units Affected
630
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.
Location
Newark, NJ

Frequently Asked Questions

What product was recalled?
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.. Recalled by Pharmaceutical Innovations, Inc.. Units affected: 630.
Why was this product recalled?
Potential for failed stability antimicrobial effectiveness testing.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1971-2019.