Events

Recall of Medex 3000 Series Syringe Infusion Pumps

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
    28699
  • Event Risk Class
    Class 2
  • Event Number
    Z-0813-04
  • Event Initiated Date
    2004-02-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32376
  • 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: medex has determined that it is possible for an extracorporeal membrane oxygenation (ecmo) circuit to generate high negative pressures on the inlet side.
  • Action
    Consignees were notified by letter starting 2/2004 and continues to the present

Device

Medex 3000 Series Syringe Infusion Pumps
  • Model / Serial
    Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.
  • Distribution
    Nationwide, China, Hong Kong & UK
  • Product Description
    Medex 3000 Series Syringe Infusion Pumps
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Manufacturer Address
    Medex Inc, 4350 River Green Pkwy Ste 200, Duluth GA 30096-8321
  • Source
    USFDA