The Recall Desk
HighFDA (Devices)·Z-1971-2019·Announced 2019-07-24

Electrode Conductivity Spray Solution Recalled for Antimicrobial Testing Failures

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure in antimicrobial effectiveness, which poses a risk of harm without reported injuries, fitting the High severity criteria.

Plain-English summary

Pharmaceutical Innovations, Inc. is recalling 630 units of ElectroMist Electrode Conductivity Spray Solution, product code 36-3310-04. The recall was initiated because of a potential for failed stability antimicrobial effectiveness testing.

The affected lots are 030215-04, 011716-04, 072816-04, 071618-04, and 080117-04. The product was distributed nationwide in the United States to accounts 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. It was also distributed internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia, and Canada.

Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions.

The recalled product

Product
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Affected units
630

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 (5)

  • Lot # 030215-04
  • 011716-04
  • 072816-04
  • 071618-04
  • 080117-04

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 →