Recall Z-0704-2020 ยท KOY Degreaser, Skin, Surgical
Bio-Signal Group Corp.
HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - 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 electrodes.
| Date | Dec 18, 2019 (initiated Oct 29, 2019) |
| Status | Terminated |
| Reason | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| Root cause | Process control |
| Action | Bio-Signal issued Email notification on 10/29/2019 advising reason for recall, health risk and action to take: Distributors - Actions to be taken: 1)Please immediately cease distribution of the affected product. 2)Please examine your inventory for the affected product, quarantine the affected product and complete the attached response form to Bio-Signal Group by email to: recall@biosignalgroup.com 3)If you have further distributed this product to: "Domestic customers: please notify your customers at once and request that they contact Bio-Signal Group directly at 978-429-8756 (Monday Friday, |
| Quantity | 1,500 tubes Expanded: 203 boxes (3/box) |
| Distribution | US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970694 | MODEL 1700, HYDRO PREP Physiometrix, Inc., May 14, 1997 |