Events

Recall of Device Recall MikroTip

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Millar Instruments, 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
    30967
  • Event Risk Class
    Class 2
  • Event Number
    Z-0635-05
  • Event Initiated Date
    2005-01-14
  • Event Date Posted
    2005-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36905
  • 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
    Wire braiding protruding from the catheter.
  • Action
    The firm initiated the recall via e-mail to direct accounts on 01/14/2005 and letter on 01/20/2005.

Device

Device Recall MikroTip
  • Model / Serial
    Lot numbers L034403 and L034731
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to distributors and hospitals in MN, CA, and NY.
  • Product Description
    Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas
  • Manufacturer
    Millar Instruments, Inc

Manufacturer

Millar Instruments, Inc
  • Manufacturer Address
    Millar Instruments, Inc, 6001-A Gulf Fwy, Houston TX 77023
  • Source
    USFDA