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

Is my product affected?

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

• UPC 00886799000687

Check against the official notice below — it lists the full affected range.

What happened

Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Module units (Catalog #802018) used with the Terumo Advanced Perfusion System 1. The flowmeter module connects the flow sensor to the system and provides flow readings during cardiac surgery procedures. The recalled units have serial numbers 01662, 01672, 01680, 01681, 01682, 01683, and 01687, and were distributed worldwide to locations in Illinois, Kentucky, Michigan, and Singapore.

The recalled flowmeter modules can display inaccurate flow readings that may be difficult for users to detect during setup or after moving or manipulating the flow probe. Depending on how far off the readings are, users might not notice the problem while operating the equipment. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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).

Details from the source

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. Quantity: 7 Lot/code info: Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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