Reported Dec 25, 2019 · Terminated
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive…
Bio-Signal Group Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Signal Group Corp. · 3 Post Office Sq Ste K · Acton, MA · 01720-3956
Is this the product you have?
- HydroDot brandWave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 -
- Product UsageAn 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
- Lot codes and dates
Lot # s 298792995830656
- ExpandedLot # 31320 and Lot #31365
- Amount recalled
- 45,375 individual cups Expanded:1314 boxes (24/box)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
This product could cause temporary or reversible health problems — stop using it.
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