Class 2 Device Recall HTron V100

• Date Initiated by Firm: July 21, 2003
• Date Posted: September 17, 2003
• Recall Status: Terminated on March 10, 2009
• Recall Number: Z-1196-03
• Recall Event ID: 26731
• 510(K)Number: K905693
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
• Code Information: All units.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: customer service; 800-688-4578
• Manufacturer Reason for Recall: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
• FDA Determined Cause: Other
• Action: An urgent product correction and removal letter dated 7/16/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
• Distribution: United States
• 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