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U.S. Department of Health and Human Services

Class 2 Device Recall Roche AccuCheck Spirit

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 Class 2 Device Recall Roche AccuCheck Spiritsee related information
Date Initiated by FirmApril 22, 2015
Date PostedJune 09, 2015
Recall Status1 Terminated 3 on November 03, 2016
Recall NumberZ-1733-2015
Recall Event ID 71235
510(K)NumberK111353 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductAccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Code Information All Serial Numbers  Models: 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.
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactACCU-CHEK Customer Care Service Center
800-688-4578
Manufacturer 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
FDA Determined
Cause 2		Device Design
ActionRoche 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 in Commerce35,795
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZG
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