Events

Recall of Vision Hollow Fiber Oxygenator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gish Biomedical 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
    26039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0780-03
  • Event Initiated Date
    2003-03-31
  • Event Date Posted
    2003-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26917
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Two reports of leakage.
  • Action
    The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.

Device

Vision Hollow Fiber Oxygenator
  • Model / Serial
    Lot 205200
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Nationwide, Austria, Canada, Japan, Saudi Arabia
  • Product Description
    Vision Hollow Fiber Oxygenator
  • Manufacturer
    Gish Biomedical Inc

Manufacturer

Gish Biomedical Inc
  • Manufacturer Address
    Gish Biomedical Inc, 22942 Arroyo Vista, Rancho Santa Margarita CA 92688
  • Source
    USFDA