Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2023