ACCU-CHEK FlexLink Plus infusion sets Recalled

Washington, DC: Roche Insulin Delivery Systems announced today that it is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK FlexLink Plus infusion set, because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels.

The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. If untreated hyperglycemia could lead to Diabetic Ketoacidosis (DKA), serious illnesses and in severe cases death.

Roche Insulin Delivery Systems emphasizes that the above mentioned action only applies to the ACCU-CHEK FlexLink Plus infusion set that was launched in November 2010. The use of the previous version ACCU -CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected and insulin pump therapy can be continued as directed with these products or other alternatives.

FEB-28-11: Roche Insulin Delivery Systems announces recall of ACCU-CHEK® FlexLink Plus infusion sets [FDA: RECALLS]

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Published on Feb-28-11