Class 2 Device Recall ElectroMist

• Date Initiated by Firm: June 19, 2019
• Create Date: July 12, 2019
• Recall Status: Terminated on July 29, 2020
• Recall Number: Z-1972-2019
• Recall Event ID: 83213
• Product Classification: Media, electroconductive - Product Code GYB
• Product: Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
• Code Information: Lot # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25
• Recalling Firm/ Manufacturer: Pharmaceutical Innovations, Inc.; 897 Frelinghuysen Ave; Newark NJ 07114-2122
• For Additional Information Contact: Mr. James Hurlman; 973-242-2900
• Manufacturer Reason for Recall: Potential for failed stability antimicrobial effectiveness testing.
• FDA Determined Cause: Other
• Action: On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) 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. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.