Device product
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - 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-0705-2020
Product summary
- Event
- Event 84305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,375 individual cups Expanded:1314 boxes (24/box)
- Official record key
device-enforcement:Z-0705-2020
Official wording
Reason: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Code information: Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365
Distribution pattern: US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Derived failure modes
-
Microbial contamination
contaminated with Burkholderia cepacia