International Biophysics Corp. recalls IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for u…

Recall date

August 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2422-2015

FDA classification

Class II

Brand / firm

International Biophysics Corp.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.