CLASS II Device recall · Reported 24 Jul 2019 · FDA Enforcement Report

Alpha Conducting solution product codes: 3310-25 ASCR recalled

Pharmaceutical Innovations is recalling Alpha Conducting solution product codes: 3310-25 ASCR, distributed nationwide in the US. The recall was initiated on 19 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1972-2019
FDA event ID: 83213
Recalling firm: Pharmaceutical Innovations, Newark, NJ
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2019
FDA classified: 12 Jul 2019
Reported: 24 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

19 Jun 2019	Recall initiated by company
12 Jul 2019	Classified by FDA	+23 days
24 Jul 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for failed stability antimicrobial effectiveness testing.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.

Where it was distributed

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.

Nationwide Arizona California Connecticut Florida Illinois Massachusetts Michigan Minnesota North Carolina New Jersey New York Ohio Pennsylvania Rhode Island Tennessee Texas Vermont West Virginia

Questions about this recall

Is Alpha Conducting solution product codes: 3310-25 ASCR recalled?

Yes. Pharmaceutical Innovations recalled Alpha Conducting solution product codes: 3310-25 ASCR on 19 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-1972-2019.

Why was it recalled?

Potential for failed stability antimicrobial effectiveness testing.

Which lots are affected?

Lot # 032014-25, 060515-25,101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, 102018A-25

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Pharmaceutical Innovations

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26 Aug 2020Device	CLASS II	Ultra/Phonic Focus BP Conforming Gel Pads recalled	Pharmaceutical Innovations	Packaging Defects	Nationwide
24 Jul 2019Device	CLASS II	Alpha Conducting solution product codes:3310-15 ACS recalled	Pharmaceutical Innovations	Potency & Assay	Nationwide
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