Acton, MA, United States
Bio-Signal Group Corp. recalls
1 recall recorded since 2018, most recently on 29 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 October 2019
- Terminated
- 7 September 2021
- Reason
- Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
- Distribution
- US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0704-2020, Z-0705-2020
- 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
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.