FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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.
Brand
Deltec, Inc
UPC
All units distributed since product introduction in December 2002 are involved.

Units Affected

913 pumps