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Bio-Signal Group Corp. recalls HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive
Recalled December 25, 2019 · FDA recall Z-0705-2020 · Bio-Signal Group
Hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) · FDA Class II
Units
45,375 individual cups Expanded:1314 boxes (24/box)
Sold at
US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Description
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
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.
Manufacturer(s)
Bio-Signal Group Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →