Recall Z-2028-2014— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2028-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2014-04-14, terminated 2016-09-07. It names one FDA 510(k) clearance: K112229. Product: Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.. Reason: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Terminated: 2016-09-07
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K112229 — SARN CENTRIFUGAL PUMPTerumo Cardiovascular Systems·cleared 2011-12-09

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 Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

Reason for recall

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

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