Events

Recall of Device Recall Gastrointestinal tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ross Products Division, Abbott Laboratories.

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
    27691
  • Event Risk Class
    Class 2
  • Event Number
    Z-0202-04
  • Event Initiated Date
    2003-11-14
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30361
  • 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
    Tubes, Gastrointestinal (And Accessories) - Product Code KNT
  • Reason
    An increase in reported balloon failures, which may result in tube displacement.
  • Action
    The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.

Device

Device Recall Gastrointestinal tube

Manufacturer

Ross Products Division, Abbott Laboratories
  • Manufacturer Address
    Ross Products Division, Abbott Laboratories, 625 Cleveland Ave, Columbus OH 43215-1754
  • Source
    USFDA