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Bio-Signal Group Recalls
2 recalls on record · December 25, 2019 to December 25, 2019 · Medical Devices
December 25, 2019Medical DevicesFDA
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
Hazard: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
December 25, 2019Medical DevicesFDA
Bio-Signal Group Corp. recalls HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes
Hazard: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)