The Recall Desk
ModerateFDA (Devices)·Z-1970-2019·Announced 2019-07-24

Pharmaceutical Innovations Recalls ElectroMist Conductivity Spray Solution

Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failure in antimicrobial effectiveness testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential failure in antimicrobial effectiveness testing, which fits the criteria for a moderate severity score involving low-risk contamination or theoretical hazards without reported harm.

Plain-English summary

Pharmaceutical Innovations, Inc. is recalling 8,982 units of ElectroMist Electrode Conductivity Spray Solution (product codes 36-3310-60). The recall affects specific lots: 051914-60, 101615-60, and 021317-60.

The recall was initiated because of a potential for failed stability antimicrobial effectiveness testing. This means the product may not maintain its intended antimicrobial properties over time.

The affected products were distributed nationwide in the United States, including in Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Tennessee, Vermont, and West Virginia. The products were also distributed internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia, and Canada. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Affected units
8,982

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 051914-60
  • 101615-60
  • 021317-60

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Pharmaceutical Innovations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →