Recall Z-0675-2020 ยท KOY Degreaser, Skin, Surgical
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 el
| Date | Nov 7, 2019 |
| Status | Terminated |
| 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 aff |
| Quantity | 3,108 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970694 | MODEL 1700, HYDRO PREP Physiometrix, Inc., May 14, 1997 |