Events

Recall of Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook OB/Gyn, 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
    52008
  • Event Risk Class
    Class 2
  • Event Number
    Z-1416-2009
  • Event Initiated Date
    2009-04-02
  • Event Date Posted
    2009-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81884
  • 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
    Endometrial Brush - Product Code HFE
  • Reason
    There is an ink on the brush which has not been tested for use with the tao brush.
  • Action
    The consignee was notified by an Urgent: Recall Notice letter dated 4/2/09. The customer is to forward the notice to all personnel that need to be aware of it; pull from their stock and isolate any affected product; and complete the form. Upon receipt of the form, Cook Women's Health will issue a Return Goods Authorization number and the customer should return the affected products via FedEx using the Return Goods Authorization number.

Device

Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush)
  • Model / Serial
    Lots UF1793872 through UF1793877, UF1811910 through UF1811913, UF1811916, UF1811917, UF1811917S, UF1811918, UF1811919, UF1816687 and UF1816688.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. || Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.
  • Manufacturer
    Cook OB/Gyn, Inc.

Manufacturer

Cook OB/Gyn, Inc.
  • Manufacturer Address
    Cook OB/Gyn, Inc., 1100 West Morgan St., Spencer IN
  • Source
    USFDA