Events

Recall of Device Recall Medex 2000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medex 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
    26633
  • Event Risk Class
    Class 2
  • Event Number
    Z-1060-03
  • Event Initiated Date
    2003-06-09
  • Event Date Posted
    2003-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28036
  • 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
    unknown device name - Product Code CAJ
  • Reason
    Inadequate warning label as pertains to use of the pump in conjunction with extracorporeal membrane oxygenation (ecmo) procedures.
  • Action
    Consignees were notified via letter dated June, 2003. The firm provided each consignee with a warning label to be affixed to all pump and to the front cover of the Instruction Manual.

Device

Device Recall Medex 2000
  • Model / Serial
    Series #2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010iK, 2010iVX, 2010iZE
  • Distribution
    Units were distributed to medical facilities nationwide and worldwide.
  • Product Description
    Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Manufacturer Address
    Medex Inc, 4350 River Green Parkway, Suite 200, Duluth GA 30096
  • Source
    USFDA