Bigfoot Biomedical is recalling 57 pen caps for its Bigfoot Unity Diabetes Management System due to a software issue in firmware version 1.3.0. The recall affects both Rapid-Acting Insulin Pen Caps (RCAP) and Long-Acting Insulin Pen Caps (LCAP) used with various insulin types including Humalog, Lantus, Novolog, and others. A software error can cause the pen cap to become unresponsive, preventing it from providing necessary insulin dose recommendations to the user. No injuries or incidents have been reported, but the defect poses a high risk to patients relying on the device for treatment decisions.
A software error may cause the insulin pen cap to stop responding or display a device error, rendering it unable to function. If the device becomes unresponsive, patients may lack the dose recommendations and information needed to manage their diabetes safely, which could lead to incorrect treatment decisions and potentially life-threatening insulin dosing errors.
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Quantity: 21 units
Quantity: 7 units
Quantity: 15 units
Quantity: 5 units
Quantity: 6 units
Quantity: 1 unit
Quantity: 1 unit
Quantity: 1 unit
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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