Recall Z-0675-2020— Neuronetrix Solutions, LLC dba Cognision
Class II · Terminated
Class II FDA medical device recall by Neuronetrix Solutions, LLC dba Cognision, initiated 2019-11-07, terminated 2020-10-26. It names one FDA 510(k) clearance: K970694. 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: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia.
- Recalling firm
- Neuronetrix Solutions, LLC dba Cognision
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-07
- Terminated
- 2020-10-26
- Firm location
- Louisville, KY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.