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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:197680

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.

Official recall number

Z-1024-2023

Evidence summary

Product code
DTZ
Recall status
Open, Classified
Event initiated
December 12, 2022
Root cause
Process change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1024-2023