Company: Deltec, Inc.
Date of Enforcement Report: 5/28/03
Class: II

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.
Recall # Z-0798-03.

REASON
A software error can result in the delivery of a larger bolus of insulin than anticipated when the pump is programmed in a particular manner.

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

RECALLING FIRM/MANUFACTURER
Deltec, Inc., St Paul, MN, by letters on March 14, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
913 pumps.

DISTRIBUTION
Nationwide.