Z-0052-2013Class II

Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in...

Name: Z-0052-2013 Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-24
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-24 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only on 2012-09-24. FDA classified it as Class II and gives the reason as "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". 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-0052-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Posted: 2012-10-11
Terminated: 2013-11-13
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees. An Addendum was sent on September 25, 2012. All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall. For questions customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 213 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
Product codes and lots: Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0052-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11
Z-0052-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11
Z-0053-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11

Product code KFM

K882758Class IICentrifugal Pump System Lx/dx Version3M Health Care, Sarns / cleared 1988-10-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)