Reported Dec 18, 2019 · Terminated
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream…
Neuronetrix Solutions, LLC dba Cognision
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neuronetrix Solutions, LLC dba Cognision · 1044 E Chestnut St · Louisville, KY · 40204-6033
Is this the product you have?
- 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 UsageAn 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
- Lot codes and dates
- Kit lot codes
NNX-100001478NNX-100001480NNX-100001481NNX-100001486NNX-100001488NNX-100001492NNX-100001542NNX-100001559NNX-100001560NNX-100001561 (containing
- Wave Prep lot codes30656)
- Kit lot codes
- Amount recalled
- 3,108 units
Where it was sold
- Nationwide
Why it was recalled
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
This product could cause temporary or reversible health problems — stop using it.
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