Class 2 Device Recall DANA Diabecare II insulin pumps

• Date Initiated by Firm: May 26, 2004
• Date Posted: September 14, 2004
• Recall Status: Terminated on December 10, 2004
• Recall Number: Z-1451-04
• Recall Event ID: 29472
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: DANA Diabecare II insulin pumps
• Code Information: Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
• Recalling Firm/ Manufacturer: Dana Diabecare USA LLC; 541 Julia Street, 3rd Floor; New Orleans LA 70130
• Manufacturer Reason for Recall: There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
• FDA Determined Cause: Other
• Action: An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.
• Distribution: AZ, WV, PA, FL, WI, MI, TN, MD
• 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.