Class 2 Device Recall Deltec Cozmo

• Date Initiated by Firm: March 14, 2003
• Date Posted: May 09, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0798-03
• Recall Event ID: 25780
• 510(K)Number: K020655
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior.
• Code Information: All units distributed since product introduction in December 2002 are involved.
• Recalling Firm/ Manufacturer: Deltec, Inc; 1265 Grey Fox Road; St Paul MN 55112
• Manufacturer Reason for Recall: A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.
• FDA Determined Cause: Other
• Action: Recall Notification letters were sent to the consignees on March 14, 2003. The letters gave recommendations for avoiding the problem, stated that updated software to prevent the problem would be introduced, and requested that the customer call a toll-free phone number to arrange replacement of their affected pump.
• Quantity in Commerce: 913 pumps
• Distribution: The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.
• 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