Device 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.
Z-0675-2020
Product summary
- Event
- Event 84324
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,108 units
- Official record key
device-enforcement:Z-0675-2020
Official wording
Reason: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Code information: 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).
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
contaminated with Burkholderia cepacia