Z-1968-2019Class II

Alpha Conducting solution product codes:3310-15 ACS -

Name: Z-1968-2019 Alpha Conducting solution product codes:3310-15 ACS -
Creator: Pharmaceutical Innovations, Inc.
Published: 2019-06-19
License: https://open.fda.gov/license/

Pharmaceutical Innovations, Inc. / initiated 2019-06-19 / Terminated

FDA source

Pharmaceutical Innovations, Inc. began a recall of Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution on 2019-06-19. FDA classified it as Class II and gives the reason as "Potential for failed stability antimicrobial effectiveness testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1968-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-19
Posted: 2019-07-12
Terminated: 2020-07-29
Recalling firm: Pharmaceutical Innovations, Inc.
Product: Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Product code: GYB Media, Electroconductive
Reason for recall: Potential for failed stability antimicrobial effectiveness testing.
FDA 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 : [email protected], 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: [email protected]
Quantity in commerce: 87140
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.
Product codes and lots: Lot # 081914-15, 111715-15, 070116-15, 020117-15, 080117-15, 010118-15, 041618-15, 041618A-15, 071618-15, 102018-15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1968-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1968-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1969-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1970-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1971-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12
Z-1972-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code GYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)