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.
Enforcement
- Recall Number
- Z-0675-2020
- Event ID
- 84324
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Neuronetrix Solutions, LLC dba Cognision
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 18, 2019
- Initiation Date
- November 7, 2019
- Classification Date
- December 12, 2019
- Termination Date
- October 26, 2020
- Address
- 1044 E Chestnut St, N/A, Louisville, KY, 40204-6033, United States
Description
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 has the potential to be contaminated with Burkholderia cepacia (B. cepacia
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).
US Nationwide distribution.
3,108 units