# FDA recall Z-0675-2020

> **Neuronetrix Solutions, LLC dba Cognision** · Class II · device recall initiated 2019-11-07.

## 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

- **Recall number:** Z-0675-2020
- **Recalling firm:** Neuronetrix Solutions, LLC dba Cognision
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0675-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0675-2020. Source: US FDA. Licensed CC0.

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