Recall Z-1733-2015 ยท LZG Pump, Infusion, Insulin
Roche Diabetes Care, Inc.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
| Date | Jun 9, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | Roche sent an URGENT MEDICAL DEVICE CORRECTION notification dated April 22, 2015, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. The recall notification included a description of the reason for the recall, customer responsibilities, training chart, and instructions for responding to the formal recall notification. Please contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-688-4578, if you have questions about the information contained in this notification. |
| Quantity | 35,795 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111353 | ACCU-CHECK COMBO SYSTEM Roche Diagnostics, Jul 17, 2012 |