Recall Z-1478-2018— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1478-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-01-19, terminated 2018-07-18. It names one FDA 510(k) clearance: K172220. Product: Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.. Reason: 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)..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Terminated: 2018-07-18
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K172220 — Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation·cleared 2017-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.