Events

Recall of Device Recall Medfusion Model 3500 Syringe Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    63621
  • Event Risk Class
    Class 2
  • Event Number
    Z-0996-2013
  • Event Initiated Date
    2010-05-14
  • Event Date Posted
    2013-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114372
  • 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
    An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
  • Action
    On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.

Device

Device Recall Medfusion Model 3500 Syringe Pump
  • Model / Serial
    Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the state of NH.
  • Product Description
    Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. || Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA