Events

Recall of Device Recall BUTTON REPLACEMENT GASTROSTOMY DEVICE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C R Bard 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
    52862
  • Event Risk Class
    Class 2
  • Event Number
    Z-2020-2009
  • Event Initiated Date
    2009-01-20
  • Event Date Posted
    2009-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84195
  • 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
    Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
  • Action
    Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.

Device

Device Recall BUTTON REPLACEMENT GASTROSTOMY DEVICE
  • Model / Serial
    Lot numbers: HUSD0118, HUSD1610 and HUSD0116.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.
  • Product Description
    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. || The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
  • Manufacturer
    C R Bard Inc

Manufacturer

C R Bard Inc
  • Manufacturer Address
    C R Bard Inc, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA