Events

Recall of Vision Hollow Fiber Oxygenator with GBS Coating

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
    28525
  • Event Risk Class
    Class 2
  • Event Number
    Z-0730-04
  • Event Initiated Date
    2004-03-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32065
  • 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
    Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
  • Reason
    Customers reported leakage.
  • Action
    Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.

Device

Vision Hollow Fiber Oxygenator with GBS Coating
  • Model / Serial
    Various
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
  • Product Description
    Vision Hollow Fiber Oxygenator with GBS Coating
  • Manufacturer
    Gish Biomedical Inc

Manufacturer

Gish Biomedical Inc
  • Manufacturer Address
    Gish Biomedical Inc, 22942 Arroyo Vis, Rancho Santa Margarita CA 92688-2600
  • Source
    USFDA