Reported Jun 17, 2015 · Terminated
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Roche Diabetes Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diabetes Care, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 05458544001, Accu-Chek Combo Kit mg US/English version. 2 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7 04759729001, Accu-Chek Spirit Replacement Pump. - Amount recalled
- 35,795
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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