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FDADecember 12, 2022device

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

medtronic perfusion systemsmedtronicmedtronic perfusion

UPCs

0064316917816800643169178175

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass. — Recall Details · AllClear