Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error
Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall (as stated in agency classification) involving a medical device that poses a risk of harm to patients with diabetes by preventing access to insulin delivery and treatment information. However, the source text states no illnesses or injuries have been reported; the hazard is a potential loss of device function that could delay treatment decisions.
Plain-English summary
Bigfoot Biomedical is recalling the Bigfoot Unity Diabetes Management System Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]), which are part of a diabetes management system that integrates continuous monitoring with insulin dose recommendations. A software/firmware issue in this system may cause a device error and render the insulin pen unresponsive and unable to function.
The affected pen caps were distributed nationwide in Alabama, Florida, Georgia, Iowa, Illinois, New York, Pennsylvania, Texas, and Washington. The recalled units include various configurations with UDI-DI codes FG-300171, FG-300173, FG-300174, FG-300175, FG-300176, FG-300179, ASM-10046, and ASM-10053, with serial numbers detailed in the recall notice.
When the pen becomes unresponsive due to this firmware error, people living with diabetes may not have all information necessary to make a timely treatment decision, creating a potential health risk. Consumers who possess affected pen caps should contact Bigfoot Biomedical for further instructions on how to proceed.
The recalled product
- Product
- Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
- Manufacturer
- BIGFOOT BIOMEDICAL
- Hazard
- firmware-error
- device-failure
- insulin-delivery-risk
Distribution
Distributed nationwide across the United States.
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