Accu-Chek infusion set recalled

April 26, 2011

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may deliver insufficient amounts of insulin to patients.

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may deliver insufficient amounts of insulin to patients.

Some customers reported that a tube kinked or bent when the infusion set was inserted. “If this remains unnoticed it can result in underdelivery, leading to elevation of blood glucose levels,” said Todd Siesky, spokesman for Roche Diabetes Care. Fourteen adverse events related to the bent tube had been reported to FDA at the time of recall, according to Siesky.

More than 140,000 Accu-Chek FlexLink Plus infusion sets have been recalled in the United States. Siesky did not know how many sets have been recalled globally. Accu-Chek FlexLink Plus was launched in November 2010, and is sold directly to patients via distributors.

Other Accu-Chek infusion sets and insulin pumps are not affected by the recall and can continue to be used by patients.

Patients should return the Accu-Chek FlexLink Plus sets to their healthcare providers or caregivers. Adverse events should be reported to FDA’s MedWatch Safety Information and Adverse Reporting program online at www.fda.gov/MedWatch or by phone at 800-332-1088.