Events

Recall of Device Recall OriGen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Origen Biomedical, 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
    31526
  • Event Risk Class
    Class 3
  • Event Number
    Z-0055-06
  • Event Initiated Date
    2002-12-16
  • Event Date Posted
    2005-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38077
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Leak between two lumens causes reduced performance.
  • Action
    The recall was initiated by letter to all consignees on 12/16/2002.

Device

Device Recall OriGen
  • Model / Serial
    Model V V 12F; Lot Number 36BC20121
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.
  • Product Description
    Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
  • Manufacturer
    Origen Biomedical, Inc

Manufacturer

Origen Biomedical, Inc
  • Manufacturer Address
    Origen Biomedical, Inc, 4020 S Industrial Dr Ste 160, Austin TX 78744-1080
  • Source
    USFDA