Events

Recall of Device Recall Gauderer Genie II PEG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. 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
    50678
  • Event Risk Class
    Class 2
  • Event Number
    Z-2180-2009
  • Event Initiated Date
    2008-12-04
  • Event Date Posted
    2009-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84349
  • 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
    Polypectomy snare for Percutaneous Endoscopic Gastrostomy - Product Code KNT
  • Reason
    Snare can detach in patient. the polypectomy snares and the entake peg system (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
  • Action
    Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.

Device

Device Recall Gauderer Genie II PEG
  • Model / Serial
    Lots: HURE3329
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • Product Description
    Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Guidewire Placement Technique REF 000375, 20F, STERILE.
  • Manufacturer
    C.R. Bard Access Systems, Inc

Manufacturer

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