Events

Recall of GISH VISION OXYGENATOR

According to Health Canada (via FOI), this recall involved a device in Canada 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
    66240
  • Event Risk Class
    II
  • Event Initiated Date
    2005-11-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Coated gish vision oxygenators are associated with an increased incidence of heat exchange leaks as a result of residual chlorides within the coating attacking the metal causing leaks within the bellows.

Device

GISH VISION OXYGENATOR
  • Model / Serial
    Model Catalog: HFOGBS (Lot serial: 151543); Model Catalog: HFOGBS (Lot serial: 122555); Model Catalog: HFOGBS (Lot serial: 088507); Model Catalog: HFOGBS (Lot serial: 067549); Model Catalog: HFOGBS (Lot serial: 047502); Model Catalog: HFOGBS (Lot serial: 047500); Model Catalog: HFOGBS (Lot serial: 035504); Model Catalog: HFOGBS (Lot serial: 338420); Model Catalog: HFOGBS (Lot serial: 231519); Model Catalog: HFOGBS (Lot serial: 215501); Model Catalog: HFOGBS (Lot serial: 151542); Model Catalog: HFOGBS (Lot serial: 047501)
  • Product Description
    Gish Vision Oxygenator with GBS Coating
  • Manufacturer
    GISH BIOMEDICAL INC.

Manufacturer

GISH BIOMEDICAL INC.
  • Manufacturer Address
    RANCHO SANTA MARGARITA
  • Source
    HC