Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter

• • 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

• • Terminated Z-1590-2008 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 g

510(k) Number

K031738 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

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See all devices from Smiths Medical MD, Inc. →