FDAFDA · Food and drugs·Recall number Z-0704-2020
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 of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
Published December 25, 2019 · Recall initiated: October 29, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bio-Signal Group Corp.
- Distributor
- US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
- Lot
- Product 1710-03: Lot # 29688 Expanded: Lot # 31160
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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