Events

Recall of Deltec Cozmo 3 mL Insulin Cartridge

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
    30401
  • Event Risk Class
    Class 2
  • Event Number
    Z-0566-05
  • Event Initiated Date
    2004-10-15
  • Event Date Posted
    2005-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35809
  • 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
    Smiths medical md, inc. (smmd) has received several complaints relating to two lots of cozmo cartridges describing leakage of insulin into the cartridge chamber. firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints.
  • Action
    Consignees were mailed Customer Recall Notification Letter on 10/15/04. Customers are to inspect their inventory for the affected lot numbers and contact Smiths Medical Customer Services Department and return any unused Insulin Cartridges to Smiths Medical, who will replace the returned Insulin Cartridges. EXPANDED RECALL Customers were notified with an Urgent: Product Safety & Recall Notification beginning 03/17/05 with similar instructions as in the previous Notification. Customers are to inspect their inventory for the affected lot number, contact Smiths Medical Diabetes System Customer Service Department to make arrangements to have the unused Insulin Cartridges from the affected lot number returned to Smiths Medical, who will provide replacement cartridges.

Device

Deltec Cozmo 3 mL Insulin Cartridge
  • Model / Serial
    Cartridge Lot Number 005X64 reorder # 21-1750-24 and Cartridge Lot Number 007X64 Reorder # 21-1750-24. EXPANDED RECALL 03/17/05 to include lot #009X64
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide. Product only distributed within the US.
  • Product Description
    Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Additional labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged. do not use if package is opened or damaged, or if product appears damaged. Made in Mexico for: Deltec 1265 Grey Fox Road, St. Paul, MN 55112 USA, Smiths, smiths Medical - a part of Smiths Group plc.
  • 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