Home / Recalls / Pharmaceutical Innovations, Inc. / Z-1970-2019

Z-1970-2019 Class II Terminated

Recalled by Pharmaceutical Innovations, Inc. — Newark, NJ

Recall Details

Product Type
Devices
Report Date
July 24, 2019
Initiation Date
June 19, 2019
Termination Date
July 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8982

Product Description

ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.

Reason for Recall

Potential for failed stability antimicrobial effectiveness testing.

Distribution Pattern

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.

Code Information

Lot # 051914-60, 101615-60, 021317-60

Other recalls by Pharmaceutical Innovations, Inc.

  • Z-2830-2020 Class II — Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 1030036 (August 13, 2020)
  • Z-1971-2019 Class II — ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Sp (June 19, 2019)
  • Z-1969-2019 Class II — ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity sp (June 19, 2019)
  • Z-1968-2019 Class II — Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode c (June 19, 2019)
  • Z-1972-2019 Class II — Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode (June 19, 2019)