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Recall Observatory FDA recall evidence

Device product

Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.

Z-1972-2019

June 19, 2019

Class II

Product summary

Firm
Pharmaceutical Innovations, Inc.
Event
Event 83213
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1972-2019

Official wording

Reason: Potential for failed stability antimicrobial effectiveness testing.

Code information: Lot # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25

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

    reason.no_named_rule · v1.0.0

    Potential for failed stability antimicrobial effectiveness testing.