Z-0989-2009

Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory...

Name: Z-0989-2009 Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory...
Creator: Smiths Medical MD, Inc.
Published: 2008-11-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-11-20 / Terminated / root cause: software

FDA source

Smiths Medical MD, Inc. began a recall of Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin... on 2008-11-20. The reason FDA records is "Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of...". 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-0989-2009
Status: Terminated
Initiated: 2008-11-20
Posted: 2009-04-16
Terminated: 2012-06-05
Recalling firm: Abbott Medical
Product: Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent a Smiths Medical "Urgent Device Recall" letter dated November 20, 2008. The letter was addressed to Distributors, Clinicians, Patients and other Customers. The letter included a Description of the Problem, Advice on Action to be Taken by the User and requested the return of the Confirmation Form. In particular, users were given the option to check the "Replacement Pump" option on the Confirmation Form initiating the process for pump replacement with a recertified pump followed by a return of the defective product. The Confirmation Form can be faxed to 1-800-628-6322 in the U.S. or 1-651-628-7485 outside the U.S., completed at www.cozmore.com/notice or calling 1-800-501-5748 in the U.S.
Quantity in commerce: 586
Distribution: Worldwide Distribution --- Including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MD, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and DC and countries of AUSTRALIA, NEW ZEALAND, UNITED KINGDOM, IRELAND, CANADA, CHINA, GREECE, POLAND, SLOVENIA, SWEDEN, ISRAEL and BRAZIL.
Product codes and lots: Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19.

Product code LZG

K062323Class IIDeltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817Smiths Medical MD, Inc. / cleared 2006-11-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)