Events

Recall of Device Recall Continuum MR Compatible Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad 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
    31565
  • Event Risk Class
    Class 2
  • Event Number
    Z-0841-05
  • Event Initiated Date
    2005-03-22
  • Event Date Posted
    2005-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38165
  • 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
    Customer complaint that a continuum infusion pump was attracted to an mr scanner due to customer not completely engaging the pump into the bracket.
  • Action
    The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one.

Device

Device Recall Continuum MR Compatible Infusion Pump
  • Model / Serial
    Serial numbers 1000 through 300017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped nationwide to hospitals and outpatient MRI office. The product was shipped to government facilities in CA, DC, MD, NJ, SC, WA, and WV. The product was also shipped to Austriala, Canada, Mexico, United Arib, Austria, Germany, Denmark, France, Great Britain, Hong Kong, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.
  • Product Description
    Continuum MR Compatible Infusion Pump. Pump Model #3009135
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA