Device product
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.
Z-0704-2020
Product summary
- Event
- Event 84305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,500 tubes Expanded: 203 boxes (3/box)
- Official record key
device-enforcement:Z-0704-2020
Official wording
Reason: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Code information: Product 1710-03: Lot # 29688 Expanded: Lot # 31160
Distribution pattern: US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Derived failure modes
-
Microbial contamination
contaminated with Burkholderia cepacia