Class 1 Device Recall Dtron

• Date Initiated by Firm: July 13, 2006
• Date Posted: September 12, 2006
• Recall Status: Terminated 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: 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