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Neuronetrix Solutions, LLC dba Cognision recalls Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream f
Recalled December 18, 2019 · FDA recall Z-0675-2020 · Neuronetrix Solutions, LLC
Hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia · FDA Class II
Units
3,108 units
Sold at
US Nationwide distribution.
Description
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
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.
Manufacturer(s)
Neuronetrix Solutions, LLC dba Cognision
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →