Events

Recall of Device Recall Tracheobronchial suction catheter.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ballard Medical Products.

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
    26542
  • Event Risk Class
    Class 2
  • Event Number
    Z-1079-03
  • Event Initiated Date
    2003-06-13
  • Event Date Posted
    2003-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27856
  • 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
    Catheters, Suction, Tracheobronchial - Product Code BSY
  • Reason
    Incorrect plug was included in the multi access catheter pkg. when inserted in the 'y' it may disengage, allowing a leak of ventilator gases.
  • Action
    All consignees were notified by letter on 06/13/2003.

Device

Device Recall Tracheobronchial suction catheter.
  • Model / Serial
    Catalog No: 1900, Lot Numbers:211006, 211830, 213674.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.
  • Manufacturer
    Ballard Medical Products

Manufacturer

Ballard Medical Products
  • Manufacturer Address
    Ballard Medical Products, 12050 S Lone Peak Parkway, Draper UT 84020
  • Source
    USFDA