Terumo Cardiovascular Systems Corporation recalls Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and…

Recall date

January 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1478-2018

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

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

Why it was recalled

Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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