Events

Recall of Tucker Embryo Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fertility Technology Resources, 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
    45413
  • Event Risk Class
    Class 2
  • Event Number
    Z-0665-2008
  • Event Initiated Date
    2007-09-13
  • Event Date Posted
    2008-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67034
  • 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
    Assisted Reproduction Catheters - Product Code MQF
  • Reason
    Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
  • Action
    All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.

Device

Tucker Embryo Catheter
  • Model / Serial
    All units shipped before August 17, 2007
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.
  • Product Description
    Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062
  • Manufacturer
    Fertility Technology Resources, Inc.

Manufacturer

Fertility Technology Resources, Inc.
  • Manufacturer Address
    Fertility Technology Resources, Inc., 4343 Shallowford Rd Ste D-4, Marietta GA 30062
  • Manufacturer Parent Company (2017)
    Fertility Technology Resources Inc.
  • Source
    USFDA