Class 2 Device Recall Dahedi

• Date Initiated by Firm: July 28, 2003
• Date Posted: September 23, 2003
• Recall Status: Terminated on January 12, 2007
• Recall Number: Z-1244-03
• Recall Event ID: 26847
• 510(K)Number: K991376
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Disetronic Dahedi insulin infusion pump; catalog # 8500019.
• Code Information: All units
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Road; Indianapolis IN 46250-0457
• For Additional Information Contact: customer service; 800-688-4578
• Manufacturer Reason for Recall: Lack of assurance of reliability.
• FDA Determined Cause: Other
• Action: A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative.
• Quantity in Commerce: 508
• 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