Safety Alerts & Recalls

What does this mean?

If you use an insulin pump delivery system, please check your supplies to see if your infusion sets are the recalled ACCU-CHEK FlexLink Plus infusion sets. If you have ACCU-CHEK FlexLink Plus infusion sets, please contact your physician or caregiver immediately to determine if any changes to your therapy are needed. You can also contact the ACCU-CHEK Customer Care Center at 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.

If you think you are experiencing symptoms of hyperglycemia, please check your blood glucose to ensure that your blood glucose level is within an acceptable range as defined by your healthcare team and follow the medical advice given by the your healthcare team or contact your physician.

Roche Announces Recall of ACCU-CHEK FlexLink Plus Infusion Sets

Roche Insulin Delivery Systems is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK FlexLink Plus infusion set, used together with insulin pump systems. The ACCU-CHEK FlexLink Plus infusion set is being recalled because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the infusion set into the pump. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels, also known as hyperglycemia. 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.

This recall 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, insulin pumps, ACCU-CHEK glucose meters, or insulin products are not affected and insulin pump therapy can be continued as directed with these products or other alternatives.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-02-24
Last Updated: 2011-02-24

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