Roche Diabetes Care, Inc. recalls AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

Recall date

April 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1733-2015

FDA classification

Class II

Brand / firm

Roche Diabetes Care, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.