Device product
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Z-1971-2019
Product summary
- Event
- Event 83213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 630
- Official record key
device-enforcement:Z-1971-2019
Official wording
Reason: Potential for failed stability antimicrobial effectiveness testing.
Code information: Lot # 030215-04, 011716-04, 072816-04, 072816-04, 071618-04, 080117-04
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.
Derived failure modes
-
Unknown
Potential for failed stability antimicrobial effectiveness testing.