FDA recall Z-0675-2020

Neuronetrix Solutions, LLC dba Cognision · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2019-11-07
Report date
2019-12-18
Termination date
2020-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2020