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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Roche Insulin Delivery Systems announces recall of ACCU-CHEK® FlexLink Plus infusion sets
Public Relations Manager
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
About Roche Diabetes Care
Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 35 years, the Accu-Chek® brand has been dedicated to enable people with diabetes to live life as normal and active as possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way. Today, the Accu-Chek® portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek® brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – leading to an improved medical outcome.
For more information please visit www.accu-chek.com.
All trademarks used or mentioned in this release are protected by law.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.