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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Bio-Signal Group Corp.: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

Agency Publication Date: December 18, 2019
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Affected Products

Product: 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.

Product 1710-03: Lot # 29688 Expanded: Lot # 31160

Lot Numbers:
29688
31160
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.

Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365

Lot Numbers:
31320
31365

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84305
Status: Resolved
Manufacturer: Bio-Signal Group Corp.
Manufactured In: United States
Units Affected: 2 products (1,500 tubes Expanded: 203 boxes (3/box); 45,375 individual cups Expanded:1314 boxes (24/box))
Agency Last Updated: December 14, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.