Roche Insulin Delivery Systems has announced the recall of its ACCU-CHEK FlexLink Plus infusion set, because of the potential for under-delivery of insulin.
The manufacturer advises all customers to stop using the infusion set and to contact their physicians or caregivers.
The recall only applies to the ACCU-CHECK FlexLink Plus set that was launched last November.
If the defect remains unnoticed, this can result in elevation of blood glucose levels.
Elevated bloog glucose, or hyperglycemia, has a number of symptoms that include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/sleepiness, headache, fruity acetone breath and abdominal pain.
Any insulin user experiencing these symptoms should check their blood glucose and contact their physician.
If untreated, hyperglycemia could lead to diabetic ketoacidosis, serious illnesses and in severe cases death
The defect in the product is due to a kinked cannula when inserting the infusion set.
Contact ACCU-CHEK Customer Care 1-800-688-4578 to receive support on obtaining alternative infusion sets. Until this issue is fixed, the FlexLink Plus infusion sets will not be available.