FDA Medical Device Recalls (openFDA)
Pharmaceutical Innovations, Inc.: ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
- Recall number
- Z-1970-2019
- Recalling firm
- Pharmaceutical Innovations, Inc.
- Product
- ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
- Status
- Terminated
- Initiated
- 2019-06-19
- Posted
- not on file
- Terminated
- 2020-07-29
- 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) 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
- Quantity
- 8982
- 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.
- Lot, serial or model codes
- Lot # 051914-60, 101615-60, 021317-60
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GYB
- Firm FEI
- 2241583
- Firm city
- Newark
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28