Z-2028-2014Class II

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

Name: Z-2028-2014 Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2014-04-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2014-04-14 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures on 2014-04-14. FDA classified it as Class II and gives the reason as "During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2028-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-07-11
Terminated: 2016-09-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.
Distribution: Nationwide Distribution
Product codes and lots: Lot No. RA07, Lot No. QP02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2028-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2028-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-11
Z-2029-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-11
Z-2030-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-11

Product code KFM

K112229Class IISarn Centrifugal PumpTerumo Cardiovascular Systems / cleared 2011-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)