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.
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 2/5 (Moderate).
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Pharmaceutical Innovations, Inc.
See all →- ModeratePharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads
FDA (Devices) · 2020-08-26
- ModeratePharmaceutical Innovations Recalls Alpha Conducting Solution for Antimicrobial Testing Failure
FDA (Devices) · 2019-07-24
- HighPharmaceutical Innovations Recalls Alpha Conducting Solution Due to Stability Testing Concerns
FDA (Devices) · 2019-07-24
- ModeratePharmaceutical Innovations Recalls ElectroMist Conductivity Spray Solution
FDA (Devices) · 2019-07-24
- HighElectrode Conductivity Spray Solution Recalled for Antimicrobial Testing Failures
FDA (Devices) · 2019-07-24
Same hazard · antimicrobial failure
See all →- ModerateCovidien Recalls Palindrome Precision SI Chronic Catheter Kits
FDA (Devices) · 2015-07-08
- ModerateTarmac Recalls Well at Walgreens Comfort Gel for Antimicrobial Failure
FDA (Drugs) · 2015-04-29
- ModerateTarmac Recalls Well at Walgreens Comfort Gel for Antimicrobial Failure
FDA (Drugs) · 2015-04-29
Similar recalls
- HighFDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighCeftazidime Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- HighFDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- ModeratePaddock Recalls Evamist Estradiol Spray Due to Vial Cracks
FDA (Drugs) · 2018-04-04
- HighPharmacy Innovations Methylcobalamin Injectable Solutions Recalled for Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighAntibiotic Eye Drops Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-02-01