Events

Recall of Device Recall Deltec Cozmo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deltec, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0798-03
  • Event Initiated Date
    2003-03-14
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26470
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, Infusion, Insulin - Product Code LZG
  • Reason
    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.
  • 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.

Device

Device Recall Deltec Cozmo
  • Model / Serial
    All units distributed since product introduction in December 2002 are involved.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide in the United States. There are no foreign or U.S. Government accounts.
  • Product Description
    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.
  • Manufacturer
    Deltec, Inc

Manufacturer

Deltec, Inc
  • Manufacturer Address
    Deltec, Inc, 1265 Grey Fox Road, St Paul MN 55112
  • Source
    USFDA