Events

Recall of Paragon Administration Set (100 ml x 0.5 ml/hr) || Part Number 5000936

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
    25777
  • Event Risk Class
    Class 2
  • Event Number
    Z-0709-03
  • Event Initiated Date
    2003-03-05
  • Event Date Posted
    2003-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26463
  • 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 - Product Code FRN
  • Reason
    Wrong component may result in over infusion of medications.
  • Action
    Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.

Device

Paragon Administration Set (100 ml x 0.5 ml/hr) || Part Number 5000936
  • Model / Serial
    Lot numbers: 262111 (manufactured June 2002, expires May 2005) 282233 (manufactured August 2002, expires July 2005)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.
  • Product Description
    Paragon Administration Set (100 ml x 0.5 ml/hr) || Part Number 5000936
  • Manufacturer
    I-Flow Corporation

Manufacturer

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