Events

Recall of Easypump LT 60-24 || Easypump Infusion Pump (60 ml x 2 ml/hr)

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
    25903
  • Event Risk Class
    Class 2
  • Event Number
    Z-0741-03
  • Event Initiated Date
    2003-03-18
  • Event Date Posted
    2003-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26695
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Overinfusion due to misassembly.
  • Action
    Recall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.

Device

Easypump LT 60-24 || Easypump Infusion Pump (60 ml x 2 ml/hr)
  • Model / Serial
    Lot numbers 04434366/2A2469 and 04434367/2A2470.
  • Product Classification
    General Hospital and Personal Use Devices
  • Distribution
    Only in France to distributor B. Braun Medical, France
  • Product Description
    Easypump LT 60-24 || Easypump Infusion Pump (60 ml x 2 ml/hr)
  • Manufacturer
    I-Flow Corporation

Manufacturer

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