Events

Recall of Millar MikroTip Disposable Angiographic Catheter (Left Heart)

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
    57015
  • Event Risk Class
    Class 2
  • Event Number
    Z-0401-2011
  • Event Initiated Date
    2010-10-14
  • Event Date Posted
    2010-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95182
  • 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
    The sterile packaging was found to be compromised when tested after shipping conditions. this may result in infection or transmission of disease. a test for transportation of sterile package was conducted and resulted in several samples failing.
  • Action
    Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131.

Device

Millar MikroTip Disposable Angiographic Catheter (Left Heart)
  • Model / Serial
    Catalog-Models: SPC-454D, SPC-454E, SPC-454F, SPC-464D. Product Code/Part No.: 800-4219-1, 800-4219-2, 800-4219-3, 802-1029X. Lot No.: L057674, L064963, L057687, L062222, L061409, L057687, L065039, L058763. S/N: 407126, 407128, 493801, 391962, 466255, 466256, 435426, 391965, 391968, 493756, 425284, 425285.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.
  • Product Description
    Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
  • Manufacturer
    Millar Instruments, Inc

Manufacturer

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