Events

Recall of Device Recall Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger 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
    34220
  • Event Risk Class
    Class 2
  • Event Number
    Z-0575-06
  • Event Initiated Date
    2005-11-28
  • Event Date Posted
    2006-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43294
  • 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
    The coated gish vision blood cardioplegia systems are associated with an increased incidence of heat exchanger leaks.
  • Action
    The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Gish Customer Service, in conjunction with the sales representative and customer pack office, will work with the consignee in an effort to resolve inventory and configuration issues.

Device

Device Recall Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS Coating
  • Model / Serial
    315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, IN, MA, MI, NJ, NY
  • Product Description
    The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.
  • Manufacturer
    Gish Biomedical Inc

Manufacturer

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