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U.S. Department of Health and Human Services

Class 1 Device Recall Dtron

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  Class 1 Device Recall Dtron see related information
Date Initiated by Firm July 13, 2006
Date Posted September 12, 2006
Recall Status1 Terminated 3 on November 05, 2007
Recall Number Z-1413-06
Recall Event ID 35771
510(K)Number K043000  
Product Classification insulin infusion pump - Product Code LZG
Product Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
Code Information Lots 06010107, 06030242, 06040085, 06050110 and 06060126.
Recalling Firm/
Manufacturer		 Disetronic Medical Systems, Inc.
11800 Exit 5 Parkway, Suite 120
Fishers IN 46038
For Additional Information Contact
800-280-7801
Manufacturer Reason
for Recall		 The battery may turn the pump off without warning due to a design change in the battery.
FDA Determined
Cause 2		 Other
Action Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.
Quantity in Commerce 6,604 packs to U.S. and Canada.
Distribution Nationwide and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LZG and Original Applicant = DISETRONIC MEDICAL SYSTEMS AG
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