FDAOctober 29, 2019device
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 elec...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
What to do
FDA enforcement status: Terminated
Brands named
bio signalbiobio signal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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