FOR IMMEDIATE RELEASE - February 21, 2011 -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. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient’s healthcare team and to follow the medical advice given by the their healthcare team or contact their physician.

Roche Insulin Delivery Systems advises all customers to discontinue use of ACCU-CHEK ® FlexLink Plus infusion set and to contact their physicians or caregivers to determine if any changes to their therapy are needed and the local ACCU-CHEK ® Customer Care 1-800-688-4578 to receive support on obtaining alternative infusion sets, such as the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion set. Until this issue is fixed, the ACCU-CHEK ® FlexLink Plus infusion sets will not be available.

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.

ACCU-CHEK Ultraflex-1 Infusion Sets
(10 per box)

The ACCU-CHEK Ultraflex infusion set features a 90-degree insertion angle, disconnect at the infusion site, kink-free tubing and tapered Teflon soft cannula for a comfortable insertion. No insertion device is necessary!

Packaged as 10 complete sets per box. ACCU-CHEK Ultraflex infusion sets are designed to work with all standard luer-lock insulin pumps, including MiniMed 506 – 508 pumps, Animas pumps and Deltec Cozmo pumps.

ACCU-CHEK Ultraflex infusion sets are not compatible with MiniMed Paradigm pumps.