Roche has recalled the Accu-Check FlexLink Plus infusion sets launched in November 2010 because of a potential for under-delivery of insulin due to a cannula that may become kinked or bent during insertion of the infusion set. If this remains unnoticed, it can result in under-delivery of insulin and hence elevation of blood glucose levels. Until this issue is resolved, Accu-Check FlexLink Plus infusion sets will not be available.
The following Part #s of Lot #s GWX 001 up to GWX 206 and GWY 001 up to GWY 033 are being recalled: 05511046001, 05511054001, 05511038001, 05510970001, 05510988001, 05510961001, 05511003001, 05511020001, 05510996001, 05510945001, 05510953001, 05510937001, and 05511089001.
Patients who have the affected products in their possession should stop using them immediately and contact their healthcare providers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the Accu-Check FlexLink Plus infusion set. Accu-Chek Ultraflex and other Accu-Check infusion sets or insulin pumps are not affected by this recall.
For more information call (800) 688-4578 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248784.htm.