Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817

• 2 recalls, same reason

  • Terminated Z-0989-2009 FDA Unclassified (pre-2012) ·initiated 20 Nov 2008
  • Terminated Z-0988-2009 FDA Unclassified (pre-2012) ·initiated 20 Nov 2008

  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

• 2 recalls, same reason

  • Terminated Z-1623-2008 FDA Unclassified (pre-2012) ·initiated 10 Mar 2008
  • Terminated Z-1622-2008 FDA Unclassified (pre-2012) ·initiated 10 Mar 2008

  Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.

• • Terminated Z-1591-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008

  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 gl

510(k) Number

K062323 ↗

FDA Product Code

LZG

Models / Variants

21-1815

21-1816

21-1817

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K072657 Active Cleared 14 Dec 2007

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  FDA 510(k) K060036 Active Cleared 17 May 2006

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See all devices from Smiths Medical MD, Inc. →

• What is the Cozmo Insulin Infusion Pump with Cozmonitor designed for?

  The Cozmo Insulin Infusion Pump with Cozmonitor is designed for continuous subcutaneous insulin infusion to manage diabetes in both hospital and outpatient settings. It integrates real-time glucose monitoring via the Cozmonitor module to enhance treatment accuracy by providing precise, programmable insulin doses tailored to patient needs.

• How is the Cozmo Insulin Infusion Pump supplied, and what components are included?

  The Cozmo Insulin Infusion Pump is supplied as a reusable pump system. It requires disposable insulin infusion sets and test strips for the Cozmonitor blood glucose meter. The pump itself is reusable, while the infusion sets and test strips are intended for single-use to ensure sterility and safety.

• Is the Cozmo Insulin Infusion Pump sterile, and how should it be handled?

  The Cozmo Insulin Infusion Pump is not pre-sterilized as a reusable device, but the disposable components—such as infusion sets and test strips—must be handled under sterile conditions to prevent contamination. Follow manufacturer guidelines for proper cleaning, disinfection, and storage of the reusable pump to maintain its functionality and safety.

• Are the models 21-1815, 21-1816, and 21-1817 interchangeable, or do they have specific uses?

  The models 21-1815, 21-1816, and 21-1817 are all authorized for use in general hospital settings under regulation number 880.5725. While they share the same core functionality, there may be minor differences in features or software versions. Always verify compatibility with your facility’s specific protocols and consult the manufacturer’s documentation to ensure proper use.

• Can the Cozmo Insulin Infusion Pump be used in environments with MRI equipment, and how should it be stored?

  The Cozmo Insulin Infusion Pump is not MRI-safe, so it should not be used or stored near MRI machines. For storage, keep the reusable pump in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for maintenance, including proper cleaning and calibration, to ensure reliable performance.