FDAJanuary 19, 2018device
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
UPCs
00886799000687
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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