Medical device recalls Moderate risk

Pharmaceutical Innovations, Inc. recalls ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

Recall date
June 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1969-2019
FDA classification
Class II
Brand / firm
Pharmaceutical Innovations, Inc.
Sold / distributed
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.

Why it was recalled

Potential for failed stability antimicrobial effectiveness testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

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