FDA-Device2015-08-26Class II
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.
International Biophysics Corp.
Hazard
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Sold states
Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Affected count
100 units
Manufactured in
Bldg 2, Ste 275, 2101 E Saint Elmo Rd, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2422-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief