Recall Z-0705-2020— Bio-Signal Group Corp.
Class II · Terminated
Class II FDA medical device recall by Bio-Signal Group Corp., initiated 2019-10-29, terminated 2021-09-07. It names one FDA 510(k) clearance: K970694. 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.. Reason: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia).
- Recalling firm
- Bio-Signal Group Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-29
- Terminated
- 2021-09-07
- Firm location
- Acton, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Data sourced from openFDA. This site is unofficial and independent of the FDA.