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.
FDA Recall Z-0798-03 · Posted 2003-05-09
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Recalling FirmDeltec, Inc
Recall StatusTerminated
Product CodeLZG
Date Initiated2003-03-14
Date Terminated2004-07-02
Product Quantity913 pumps
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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