Neuronetrix Solutions, LLC dba Cognision recalls Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream…

Recall date

November 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0675-2020

FDA classification

Class II

Brand / firm

Neuronetrix Solutions, LLC dba Cognision

Sold / distributed

US Nationwide distribution.

Why it was recalled

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.