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…
- Recall date
- October 29, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0705-2020
- FDA classification
- Class II
- Brand / firm
- Bio-Signal Group Corp.
- Sold / distributed
- US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Why it was recalled
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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