Roche recalls insulin infusion set
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Roche Insulin Delivery Systems has recalled the Accu-Chek FlexLink Plus insulin infusion set because of the potential for underdelivery of insulin.
The product may have a kinked or bent cannula when inserting the infusion set, leading to insufficient insulin delivery and potential hyperglycemia.
The recall applies only to the Accu-Chek FlexLink Plus infusion set that was launched in November 2010, according to an FDA release. Use of the previous version of Accu-Chek Ultraflex or other Accu-Chek infusion sets or insulin pumps are not affected by the recall.
Patients and health care professionals are encouraged to discontinue use of any Accu-Chek FlexLink Plus infusion sets, and professionals should discuss changes to therapy with patients.
Roche customer care can provide support for obtaining alternative infusion sets. Until this issue is fixed, the Accu-Chek FlexLink Plus infusion sets will not be available.