Events

Recall of Eclipse Infusion Pump, 250 ml X 250 ml per hour) || Part 5001247

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by I-Flow Corporation.

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
    27911
  • Event Risk Class
    Class 2
  • Event Number
    Z-0312-04
  • Event Initiated Date
    2002-08-19
  • Event Date Posted
    2004-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30728
  • 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, Elastomeric - Product Code MEB
  • Reason
    Slower than expected infusion of medications, such as antibiotics.
  • Action
    All customers were contacted by telephone on 8/19/2002. Letters were also sent dated 8/27/2002. Recall is complete.

Device

Eclipse Infusion Pump, 250 ml X 250 ml per hour) || Part 5001247

Manufacturer

I-Flow Corporation
  • Manufacturer Address
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA