Z-0798-03

Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3...

Name: Z-0798-03 Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3...
Creator: Deltec, Inc
Published: 2003-03-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-03-14 / Terminated / root cause: software

FDA source

Deltec, Inc began a recall of 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 on 2003-03-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0798-03
Status: Terminated
Initiated: 2003-03-14
Posted: 2003-05-09
Terminated: 2004-07-02
Recalling firm: Abbott Medical
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.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: software
FDA root 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.
Product codes and lots: All units distributed since product introduction in December 2002 are involved.

Product code LZG

K020655Class IIDeltec Insulin Infusion Pump and AccessoriesDeltec, Inc. / cleared 2002-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)