Pharmaceutical Innovations Recalls ElectroMist Electrode 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 and involves a potential failure in antimicrobial testing without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution, product code 36-3310-25. The recall involves 71,653 units distributed nationwide in the United States and internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia, and Canada.
The recall was initiated due to a potential for failed stability antimicrobial effectiveness testing. The affected lots include 060714-25, 080614-25, 101515-25, 070116-25, 072816-25A, 072816-25, 021317-25, 010118-25, and 102018-25.
Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions or a return.
The recalled product
- Product
- ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
- Manufacturer
- Pharmaceutical Innovations, Inc.
- Hazard
- Affected units
- 71,653
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 (9)
- Lot # 060714-25
- 080614-25
- 101515-25
- 070116-25
- 072816-25A
- 072816-25
- 021317-25
- 010118-25
- 102018-25.
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.
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