Affinity Fusion Oxygenator with Integrated Arterial recall
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Why was Affinity Fusion Oxygenator with Integrated Arterial recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)
- Product
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 2,937 units
- Distribution
- 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.
- Recall date
- February 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)