United StatesThe iLet Ace Pump Kit (REF: BB1001) running iLet Dosing Decision Software versions 1.3.7, 1.4.2, or 1.4.3 — identified as iLet Ace Pumps containing software BOM000036 Rev C (version 1.4.2) or older — is affected. Certain icons on the Lock Screen and Limited Access Passcode Screen are active, allowing the screens to be bypassed and unauthorized access while the device is in Limited Access Mode. This could lead to severe hypoglycemia if someone makes unauthorized meal announcements or stops insulin delivery.
What's being recalled
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Recalling firm: Beta Bionics, Inc., Irvine, CA, United States.
How to identify it
ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
The hazard
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY AND WASHINGTON DC.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)