Roche Insulin Delivery Systems announces recall of ACCU-CHEK FlexLink Plus infusion sets
MedSun: Newsletter #59, April 2011

FDA Press Release

Roche Insulin Delivery Systems announced today that it is notifying its customers and healthcare professionals about the recall of the ACCU-CHEKĀ® 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.

Additional Information:

FDA Press Release. Roche Insulin Delivery Systems announces recall of ACCU-CHEKĀ® FlexLink Plus infusion sets. February 21, 2011.
http://www.fda.gov/Safety/Recalls/ucm244487.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun