BEUDAMED
    FDA Enforcement Class II Terminated

    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

    Recall: Z-2422-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2422-2015
    Event ID
    71911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    International Biophysics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 26, 2015
    Initiation Date
    August 7, 2015
    Classification Date
    August 19, 2015
    Termination Date
    March 1, 2016
    Address
    Bldg 2, Ste 275, 2101 E Saint Elmo Rd, Austin, TX, 78744-1015, United States

    Description

    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

    Reason

    It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

    Code Info

    033115-3445

    Distribution

    Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

    Quantity

    100 units