Recall Z-1970-2019— Pharmaceutical Innovations, Inc.
Class II · Terminated
Class II FDA medical device recall by Pharmaceutical Innovations, Inc., initiated 2019-06-19, terminated 2020-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.. Reason: Potential for failed stability antimicrobial effectiveness testing..
- Recalling firm
- Pharmaceutical Innovations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-19
- Terminated
- 2020-07-29
- Firm location
- Newark, NJ, United States
Product description
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Reason for recall
Potential for failed stability antimicrobial effectiveness testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.