Events

Recall of Gastrointestinal tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access Systems, 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
    35140
  • Event Risk Class
    Class 2
  • Event Number
    Z-0839-06
  • Event Initiated Date
    2006-04-06
  • Event Date Posted
    2006-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45407
  • 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
    Tube, Gastro-Enterostomy - Product Code KGC
  • Reason
    Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. an underinflated balloon may cause misplacement, slippage or premature removal of the tube. if an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. this carries the risk of infection.
  • Action
    Consignees were notified by letter on 04/06/2006.

Device

Gastrointestinal tube
  • Model / Serial
    Product Code 00724. Lot numbers: NGPL2272, NGPL2556.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including 4 VA facilities. No military consignees. Foreign distribution to Canada, Australia
  • Product Description
    24F Tri-Funnel Replacement Gastrostomy Tube
  • Manufacturer
    Bard Access Systems, Inc

Manufacturer

Bard Access Systems, Inc
  • Manufacturer Address
    Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA