Home / Recalls / International Biophysics Corp. / Z-2422-2015

Z-2422-2015 Class II Terminated

Recalled by International Biophysics Corp. — Austin, TX

Recall Details

Product Type: Devices
Report Date: August 26, 2015
Initiation Date: August 7, 2015
Termination Date: March 1, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100 units

Product 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 for Recall

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

Distribution Pattern

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

Code Information

033115-3445