Events

Recall of IBC Suction Wand

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
    35703
  • Event Risk Class
    Class 2
  • Event Number
    Z-1222-06
  • Event Initiated Date
    2005-08-16
  • Event Date Posted
    2006-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46689
  • 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
    Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
  • Reason
    Tyvek pouches containing device labeled as sterile have defective seals.
  • Action
    Firm notified customer via telephone on 08/16/05.

Device

IBC Suction Wand
  • Model / Serial
    Lot #042805-100335.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to one hospital located in FL.
  • Product Description
    IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; 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