Events

Recall of Device Recall VariSource AL13198000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alpha Omega Services 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
    34969
  • Event Risk Class
    Class 2
  • Event Number
    Z-0820-06
  • Event Initiated Date
    2006-02-21
  • Event Date Posted
    2006-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45046
  • 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
    System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
  • Reason
    There is a possibility that the diameter of the catheter does not meet specifications. as a result it may not be possible to correctly connect the catheter to a varisource quick connect. this would prevent any treatment. furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation procedure would have taken place.
  • Action
    Recall Notification Letter: began February 22, 2006. Depth/Scope: 100% of the customer''s who purchased the affected products will be identified and contacted with a faxed and mailed Medical Device Recall notice and followed up with a phone call by the AOS Sales & Marketing personnel. All customers will be requested return all affected products, both used and unused.

Device

Device Recall VariSource AL13198000
  • Model / Serial
    All Lots
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela
  • Product Description
    VariSource AL13198000, Intralumenal Kit
  • Manufacturer
    Alpha Omega Services Inc

Manufacturer

Alpha Omega Services Inc
  • Manufacturer Address
    Alpha Omega Services Inc, 9156 Rose St, Bellflower CA 90706
  • Source
    USFDA