Z-0675-2020 Class II Terminated
FDA device recall Z-0675-2020 was initiated by Neuronetrix Solutions, LLC dba Cognision on November 7, 2019 and is designated Class II. Reason for recall: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia The recall status is terminated (terminated October 26, 2020). Affected quantity: 3,108 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 7, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,108 units
Product 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.
Reason for Recall
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Distribution Pattern
US Nationwide distribution.
Code Information
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).