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
    60123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0273-2012
  • Event Initiated Date
    2011-10-05
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104488
  • 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
    Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
  • Reason
    Potential for the sterility to be compromised.
  • Action
    International Biophysics Corp. sent a" Medical Device Recall Notice" dated October 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use of the product in the referenced lot number should cease immediately. Customers were asked to follow the instructions in the letter to return the affected product. If you have any further questions please call (512) 814-0070.

Device

IBC Suction Wand
  • Model / Serial
    IBC 041811-2065
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AZ, CA, CO, DE, MS, OR, PA, TN, and TX
  • Product Description
    IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 || For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.
  • 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