Events

Recall of Device Recall Medfusion 3500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    37590
  • Event Risk Class
    Class 2
  • Event Number
    Z-0768-2007
  • Event Initiated Date
    2007-02-03
  • Event Date Posted
    2007-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50929
  • 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
    Infusion Pump - Product Code FRN
  • Reason
    Software anomaly that causes the pump to experience a sudden and unexpected failure. this anomaly occurs during the pump's startup sequence when the pump's preventative maintenance alarm goes off, preventing the pump from completing its power up routine. lock-up occurs and the pump will not function.
  • Action
    Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.

Device

Device Recall Medfusion 3500
  • Model / Serial
    Model 3500 pump with 4.1.4 or 4.1.3 software.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, and Italy.
  • Product Description
    Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA