Recall Z-1969-2019 ยท GYB Media, Electroconductive
Pharmaceutical Innovations, Inc.
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
| Date | Jun 19, 2019 |
| Status | Terminated |
| Reason | Potential for failed stability antimicrobial effectiveness testing. |
| Root 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) Pharmaceuti |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.