Terumo Advanced Perfusion System 1

System for heart-lung machine

Model: 801764, Affected: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1429

Model: 801764, Affected: All units

Model: Base for Terumo Advanced Perfusion System 1, Affected: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445,1447-1450

Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.

Flowmeter Module (accessory to Terumo Advanced || Perfusion System 1). || Provides the interface between the flow sensor and the system.