Z-1972-2019 Class II Terminated
FDA device recall Z-1972-2019 was initiated by Pharmaceutical Innovations, Inc. on Jun 19, 2019 and is designated Class II. Reason for recall: Potential for failed stability antimicrobial effectiveness testing. The recall status is terminated (terminated Jul 29, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2019
- Initiation Date
- Jun 19, 2019
- Termination Date
- Jul 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Alpha Conducting solution product codes: 3310-25 ASCR - 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 # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25