AccuChek Spirit insulin infusion pump.
Reported: June 17, 2015 Initiated: April 22, 2015 #Z-1734-2015
Product Description
AccuChek Spirit insulin infusion pump.
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
Details
- Recalling Firm
- Roche Diabetes Care, Inc.
- Units Affected
- 35,795
- Distribution
- Nationwide Distribution
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
AccuChek Spirit insulin infusion pump.. Recalled by Roche Diabetes Care, Inc.. Units affected: 35,795.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1734-2015.
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