Events

Recall of Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) || Model Number 2005-001

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Harvard Clinical Technology.

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
    30301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0433-05
  • Event Initiated Date
    2004-11-03
  • Event Date Posted
    2005-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35685
  • 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, Pca - Product Code MEA
  • Reason
    Potential pump motor/encoder assembly failure may cause over infusing medication in patients.
  • Action
    Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.

Device

Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) || Model Number 2005-001
  • Model / Serial
    Serial number range 218002222 - 218002382  02R00222 - 02R002382 318002383 - 318002426
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
  • Product Description
    Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) || Model Number 2005-001
  • Manufacturer
    Harvard Clinical Technology

Manufacturer

Harvard Clinical Technology
  • Manufacturer Address
    Harvard Clinical Technology, 22 Pleasant Street, Natick MA 01760
  • Source
    USFDA