Events

Recall of Device Recall Easy Pump LT 6024

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
    50802
  • Event Risk Class
    Class 2
  • Event Number
    Z-2111-2009
  • Event Initiated Date
    2008-02-11
  • Event Date Posted
    2009-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77342
  • 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
    I-flow corporation received two complaints involving easypump lt 60-24 (lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (illustration was included to show consignee what both the correct and incorrect part looks like). lot 612996 was manufactured on january 6, 2006. as of february 7, 2008, there have been no further complaints received on t.
  • Action
    I-Flow Corp. issued an "Important Recall Information" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot. For further information, contact I-Flow Corp. at 1-949-206-2653.

Device

Device Recall Easy Pump LT 6024
  • Model / Serial
    Lot Number: 612996.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.
  • Product Description
    I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. || The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.
  • Manufacturer
    I-Flow Corporation

Manufacturer

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