FDA recall Z-1478-2018

Product

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

Reason for recall

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).

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-19

Report date

2018-05-02

Termination date

2018-07-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2018