Z-0675-2020Class II

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep...

Name: Z-0675-2020 Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep...
Creator: Neuronetrix Solutions, LLC dba Cognision
Published: 2019-11-07
License: https://open.fda.gov/license/

Neuronetrix Solutions, LLC / initiated 2019-11-07 / Terminated / root cause: manufacturing process

FDA source

Neuronetrix Solutions, LLC dba Cognision began a recall of Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order... on 2019-11-07. FDA classified it as Class II and gives the reason as "Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0675-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Posted: 2019-12-12
Terminated: 2020-10-26
Recalling firm: Neuronetrix Solutions, LLC
Product: Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep cups are a component in the Subject Kit.
Product code: KOY Degreaser, Skin, Surgical
Reason for recall: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cognison notified customers and/or end users via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep cups were initially notified by phone on 11/7/2019. All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take: Please review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above. Customers have been instructed to dispose of the affected product as medical waste. Customer to return notice via email to [email protected]. If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product. Alternatively, you mail email [email protected] and provide this information
Quantity in commerce: 3,108 units
Distribution: US Nationwide distribution.
Product codes and lots: Kit lot codes: NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 (containing Wave Prep lot codes: 30656).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0675-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0675-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code KOY

K970694Class IIModel 1700, Hydro PrepPhysiometrix, Inc. / cleared 1997-05-14

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)