Electromedical Products International, Inc.
July 9, 2019
MEDICAL DEVICE RECALL
Alpha Conducting Solution Product Codes:
ACS and ACSR
July 9, 2019
Dear Alpha-Stim® Customer,
The purpose of this letter is to advise you that Pharmaceutical Innovations, Inc. is voluntarily recalling their ElectroMist Conductive Spray which is manufactured as a private label for Electromedical Products International, Inc. (EPI) under our brand name Alpha Conducting Solution. Alpha Conducting Solution may be found as part of your Alpha-Stim M or Alpha-Stim AID device in a small 15 ml size; or it may have been purchased as a replacement to the smaller solution bottle in a 250 ml bottle.
No reports of serious injuries and/or deaths have occurred as a result of the failure of the product.
Reason for the Voluntary Recall:
The ElectroMist / ACS Stability Study failed to meet the requirements for the Antimicrobial Effectiveness Test. Product samples failed to meet the USP <51> category 2.
- Frequency of failures and complaints: We are not aware of any complaints or Medical Device Reports associated with the product.
- Magnitude of the error: Lots manufactured from 2014 through 2019.
Risk to Health:
The product may not have the capability to effectively control the contamination of the conducting solution over time. The products failure to prevent contamination could lead to injuries associated with, but not limited to, the following; Candida albicans, Aspergillus niger Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus.
“How to recognize that the conducting solution may fail.” The contamination, if present, will not be readily visible to the naked eye. It is important that you assume the product is contaminated and follow the directions for return and/or disposal back to EPI.
Actions to be taken by the Customer/User:
Please examine your inventory for any of the conduction solution listed below and;
- Isolate and quarantine these products,
- Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed.
- EPI will send you a confirmation of receipt of the Recall Response Form for your records.
- All replacement requests must be accompanied by a photograph of actual product, showing the lot number, to receive a replacement of another brand of conducting solution. Click here to complete an ACS replacement request form.
Cindy Mercer, Recall Coordinator
Monday through Friday, 8:30 AM to 3:30 PM, Central Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Tracey B. Kirsch
Electromedical Products International, Inc
MEDICAL DEVICE RECALL RETURN RESPONSE
Acknowledgement and Receipt Form
Response is Required