Events

Recall of Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kit

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
    28421
  • Event Risk Class
    Class 2
  • Event Number
    Z-0703-04
  • Event Initiated Date
    2004-03-01
  • 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=31934
  • 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
    The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.
  • Action
    The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.

Device

Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kit
  • Model / Serial
    Lot Numbers: 03620GZ00, 83545GZ00, 85651GZ00, 87789GZ00, 89926GZ00, 92196GZ00, 92221GZ00, 85636GZ00, 89896GZ00, 91138GZ00.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide; Australia, New Zealand, Italy.
  • Product Description
    Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm length, Item Numbers: 54230 || and 55725.
  • Manufacturer
    Ross Products Division Abbott Laboratories

Manufacturer

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