Events

Recall of Device Recall RAD SOURCE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rad-Source Technologies, 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
    26998
  • Event Risk Class
    Class 3
  • Event Number
    Z-0745-04
  • Event Initiated Date
    2002-06-01
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28970
  • 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
    Elisa, Trichinella Spiralis - Product Code MDT
  • Reason
    The firm completed a cooling system retrofit to preclude overheating and failure.
  • Action
    The firm e-mailed a notification on May 9, 2002 to its consignees giving them instructions on using additional radiation indictors to assure that the blood units were correctly irradiated. They also initiated a cooling tube retrofit of all units on that date and this was completed on 8/13/2002.

Device

Device Recall RAD SOURCE
  • Model / Serial
    Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Units were distributed to 20 blood banks and transfusion services in WI, KS, IN, MI, GA, NC, WA, NE, FL, IN, TX, MD, Washington DC, SC, and NM.
  • Product Description
    RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
  • Manufacturer
    Rad-Source Technologies, Inc.

Manufacturer

Rad-Source Technologies, Inc.
  • Manufacturer Address
    Rad-Source Technologies, Inc., 20283 State Rd. 7, Suite 107, Boca Raton FL 33498
  • Source
    USFDA