Z-1590-2008

Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous...

Name: Z-1590-2008 Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous...
Creator: Smiths Medical MD, Inc.
Published: 2008-02-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-02-22 / Terminated / root cause: design

FDA source

Smiths Medical MD, Inc. began a recall of Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder... on 2008-02-22. The reason FDA records is "Smith Medical has received reports of Deltec Cozmo Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief "chirp" will...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1590-2008
Status: Terminated
Initiated: 2008-02-22
Posted: 2008-09-01
Terminated: 2011-01-19
Recalling firm: Abbott Medical
Product: Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Smith Medical has received reports of Deltec Cozmo Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood g
Root cause tag: design
FDA root cause: Device Design
Action: Consignees and the USA demonstration pump physicians were mailed an "Urgent Medical Device Correction" letter on 2/22/08. The letter stated Details on Affected devices, Description of the problem, Advice on action to be taken by the user, Additional Information and New Warning. These consignees will be required to return the Correction Confirmation Form. The 17 countries with international mailing addresses were sent the Urgent Medical Device Correction letter (Urgent Field Safety Notice) via the Smiths Medical International Regulatory department based in Watford UK. The Smiths Medical Distributors and Affiliates will be required to mail the Safety Notice to their direct users. The USA distributors were mailed the Urgent Medical Device correction letter with a cover letter. These consignees will be required to add the letter to in-house inventory. The USA prescribing physician and the the USA Managed Care Accounts (Insurance Companies) were mailed the Urgent Medical Device Correction letter with a cover letter. These consignees will not be required to respond and no follow-up will be done by Smiths Medical. Contact Mike Herbert at 651-628-7049 if you have any questions or did not receive the recall information from the firm.
Distribution: Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of AU, CA, CL, CN, DE, EG, FR, GB, GR, IL, KW, MX, NL, NZ, ON, PL, SA, SE, TR, UK.
Product codes and lots: all serial numbers

Product code LZG

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)