The Recall Desk

FDA (Devices) recall action 84305

Bio-Signal Group Corp. recalled 2 products on 2019-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-12-25
Critical
0
Units
—

Why these products were recalled

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep single-use cups due to potential contamination with Burkholderia cepacia. The product is distributed in six US states.

    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 wit
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Electroconductive Cream

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep electroconductive cream due to potential contamination with Burkholderia cepacia.

    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.
    Category
    Distribution
    6 states