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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Manufacturer
- Pharmaceutical Innovations, Inc.
- Hazard
- 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
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 →Related recalls
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