Events

Recall of IBC FloProbe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Biophysics Corp.

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
    35704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1223-06
  • Event Initiated Date
    2005-04-22
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46643
  • 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
    Probe, Blood-Flow, Extravascular - Product Code DPT
  • Reason
    Complaints received regarding the device's failure to zero out.
  • Action
    Firm notified customers via e-mail and phone calls starting on 04/22/05.

Device

IBC FloProbe
  • Model / Serial
    Lot #122004-100217 and #030805-100279.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.
  • Product Description
    IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.
  • Manufacturer
    International Biophysics Corp

Manufacturer

International Biophysics Corp
  • Manufacturer Address
    International Biophysics Corp, 2101-2 E Saint Elmo, Ste 275, Austin TX 78744
  • Source
    USFDA