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U.S. Department of Health and Human Services

Class 2 Device Recall Roche ACCUCHEK Spirit Plus insulin pump

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 Class 2 Recall
Roche ACCUCHEK Spirit Plus insulin pump
see related information
Date Posted May 26, 2009
Recall Status1 Open
Recall Number Z-1646-2009
Recall Event ID 51695
Premarket Notification
510(K) Number
K060876 
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
Code Information All units with serial numbers SN02119552 thru SN10006093.
Recalling Firm/
Manufacturer
Disetronic Medical Systems, Inc.
11800 Exit 5 Pkwy Ste 120
Fishers, Indiana 46037-7989
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification. On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.
Quantity in Commerce 14,929
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = DISETRONIC MEDICAL SYSTEMS AG
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