FDA Medical Device Recalls (openFDA)
Neuronetrix Solutions, LLC dba Cognision: 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.
- Recall number
- Z-0675-2020
- Recalling firm
- Neuronetrix Solutions, LLC dba Cognision
- 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.
- Status
- Terminated
- Initiated
- 2019-11-07
- Posted
- not on file
- Terminated
- 2020-10-26
- Reason
- Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
- Root cause
- Process control
- Action
- Cognison notified customers and/or end users via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep cups were initially notified by phone on 11/7/2019. All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take: Please review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above. Customers have been instructed to dispose of the affected product as medical waste. Customer to return notice via email to support@cognision.com. If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product. Alternatively, you mail email support@cognision.com and provide this information
- Quantity
- 3,108 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K970694"]
- PMA numbers
- not on file
- Product code
- KOY
- Firm FEI
- 3011184129
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28