AccuChek Spirit insulin infusion pump.
FDA device recall Z-1734-2015 · posted 2015-06-09 · Terminated
Recall details
- Recalling firm
- Roche Diabetes Care, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 35,795
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-04-22
- Date posted
- 2015-06-09
- Date terminated
- 2016-11-03
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK SPIRIT (K042887) | Disetronic Medical Systems AG | 2005-03-18 |