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Roche Diabetes Care, Inc. recalls AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Recalled June 17, 2015 · FDA recall Z-1733-2015 · Roche Diabetes Care
Hazard
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 · FDA Class II
Units
35,795
Sold at
Nationwide Distribution
Description
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
Product
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Manufacturer(s)
Roche Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →