Defective <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">ACCU-CHEK FlexLink Plus Infusion Sets are being recalled for potential under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the defective medical device, the U.S. Food and Drug and Administration (FDA) just announced. If this goes unnoticed, this defect could result in under-delivery or no delivery of insulin, which can lead to elevated blood glucose levels (hyperglycemia), which can lead to many significant health complications, including death.
This recall has been designated a Class I, the FDAâ€™s most serious recall classification, which involves situations in which there is a reasonable probability that use of the defective product will cause serious adverse health consequences or death.
This recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. This product delivers insulin from a pump to the body and was manufactured and distributed from November 1, 2010 through February 20, 2011 by. Until corrected, the ACCU-CHEK FlexLink Plus infusion sets will NOT be available. The recall was implemented by Roche Insulin Delivery Systems, Inc.â€¨11800 Exit 5 Parkway, Suite 120â€¨Fishers, Indiana 46037-7989. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can continue to be used as directed by a physician or other qualified health care provider. Recalled ACCU-CHEK FlexLink Plus Infusion Set part and lot numbers are:
â€¢ Lot Numbers: GWX 001 up to GWX 206 and GWY 001 up to GWY 033
â€¢ Part Numbers: 05511046001, 05511054001, 05511038001, 05510970001, 05510988001, 05510961001, 05511003001, 05511020001, 05510996001, 05510945001, 05510953001, 05510937001, and 05511089001.
On February 21, 2011, Roche/ACCU-CHEK sent its customers an Urgent Product Recall Letter that identified the affected product, described the defect, and requested patients to stop using the ACCU-CHEK FlexLink Plus infusion sets and to return the unused products. Patients are to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The Customer Reply Card should be completed and returned by mail or FAX according to the instructions on the card. The letter also lists additional information pertaining to signs and symptoms of hyperglycemia. ACCU-CHEK Customer Care can be reached, toll-free, at 1.800.688.4578, 24 hours a day, seven days a week.
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), a serious illnesses; in severe cases, hyperglycemia could lead to 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 patientâ€™s healthcare team and to follow the medical advice given by the their healthcare team or contact their physician. â€¨
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm; download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm; call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form; or submit by fax to 1.800.FDA.0178.