FDAAugust 1, 2019device
Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire,...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
What to do
FDA enforcement status: Ongoing
Brands named
gn otometrics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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