Events

Recall of Deltec Cozmo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    30161
  • Event Risk Class
    Class 2
  • Event Number
    Z-0210-05
  • Event Initiated Date
    2004-09-18
  • Event Date Posted
    2004-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35288
  • 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
    The vibratory alarm motor installed in a small number of deltec cozmo insulin pumps may function intermittently.
  • Action
    All customers were contacted and instructed to only use the Beeper alarm function and not the vibrate alarm feature. Patients were instructed to return the affected pump to Smiths Medical MD upon receipt of the replacement pump.

Device

Deltec Cozmo
  • Model / Serial
    Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A207742
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    371 = Number of Individual Product Manufactured 6 = Number of Product Distributed to Patients 365 = Number of Products Either at Smiths Medical MD or at the Distributor or with a Smiths Medical MD Sales Rep.
  • Product Description
    Deltec Cozmo Insulin Pump
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA