United StatesTandem insulin infusion pumps (battery-operated basal and bolus pumps), Version 7.8.1, UDI (01)008500066132625, distributed in the Czech Republic and Slovakia, are affected. They were recalled because the Czech-language user guide contains translation errors, including an instruction that incorrectly tells users to verify the infusion set is connected to the body instead of not connected, which could lead to unintended insulin delivery and a hypoglycemic event.
What's being recalled
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
Recalling firm: Tandem Diabetes Care, Inc., San Diego, CA, United States.
How to identify it
Version 7.8.1/ UDI: (01)008500066132625
The hazard
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
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
International distribution in the countries of Czech Republic, Slovakia.
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)