Recall Z-2422-2015— International Biophysics Corp.

Name: FDA recall Z-2422-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Class II · Terminated

Class II FDA medical device recall by International Biophysics Corp., initiated 2015-08-07, terminated 2016-03-01. It names one FDA 510(k) clearance: K963756. Product: 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..

Recalling firm: International Biophysics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Terminated: 2016-03-01
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K963756 — IBC CARDIAC SUCTION WARDInternational Biophysics Corp.·cleared 1997-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.