medical Class II Updated 2019-12-18

Neuronetrix Solutions, LLC dba Cognision recalls Cognision, Subject Kit (Clinical Grade), Model 3000- contain

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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).
View official government recall

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