Roche Announces Recall of ACCU-CHEX FlexLink Plus Infusion Sets (2/21/11)

Roche Insulin Delivery Systems announced on 2/21/11 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 the ACCU-CHEK ® FlexLink Plus infusion set. They should 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.

For more information visit www.accu-chek.com.

Note: All trademarks used or mentioned in this release are protected by law.

Source: http://www.fda.gov/Safety/Recalls/ucm244487.htm