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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:108621

Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

Official recall number

Z-2043-2012

Evidence summary

Product code
DTQ
Recall status
Terminated
Event initiated
June 18, 2012
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2043-2012

Field note

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