FDAClass IIJuly 24, 2019

ElectroMist recall: Contamination

ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

Why was ElectroMist recalled?

Potential for failed stability antimicrobial effectiveness testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 060714-25, 080614-25, 101515-25, 070116-25, 072816-25A, 072816-25, 021317-25, 010118-25,102018-25.

Product
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
Recalling firm
Pharmaceutical Innovations, Inc.
Quantity
71653
Distribution
US nationwide distribution including the states of AZ, CA, CT, FL, IL, MA, MI, MN, NC, NJ, NY, OH, PA, RI, TX, TN, VT, WV. Distributed Internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia and Canada.
Recall date
July 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls