RecallDepth

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.

Company
Deltec, Inc
Recall Initiated
March 14, 2003
Posted
May 9, 2003
Terminated
July 2, 2004
Recall Number
Z-0798-03
Quantity
913 pumps
Firm Location
St Paul, MN

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.

Distribution

The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.

Lot / Code Info

All units distributed since product introduction in December 2002 are involved.

Root Cause

Other

Action Taken

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.

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