Louisville, KY, United States
Neuronetrix Solutions, LLC dba Cognision recalls
1 recall recorded since 2018, most recently on 7 November 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 November 2019
- Terminated
- 26 October 2020
- Reason
- Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0675-2020
- 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 electrocondu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.