Recall Z-0051-2013— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0051-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-24

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-09-24, terminated 2013-11-13. It names one FDA 510(k) clearance: K882758. Product: Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.. Reason: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Terminated: 2013-11-13
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K882758 — CENTRIFUGAL PUMP SYSTEM LX/DX VERSION3M Health Care, Sarns·cleared 1988-10-13

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

Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

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