Z-0128-2013Class II

Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000...

Name: Z-0128-2013 Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-25 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the... on 2012-09-25. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0128-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-25
Posted: 2012-10-24
Terminated: 2015-08-21
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13. Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551. For questions customers were instructed to call 1-800-521-2818.
Quantity in commerce: 466 units
Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, CALLO PERU, CANADA, CAROLINA PR, CHILE, China, COLOMBIA, Costa Rica, DEKALB, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, Germany, GUAYQUIL ECUADOR, Hong Kong, India, Indonesia, ITALY, Japan, , JARAMA MADRID, Lebanon, LEICESTERSHIRE, MADRID SPAIN, MADRID SPAIN, Malaysia, MEDLEY, Mexico, D.F., MIAMI, MUMBAI 26 INDIA, MUMBAI, New Zealand, Nicaragua, Pakistan, Panama, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, SELANGOR, MALAYSA, SEOUL, KOREA, Singapore, SOUTH AFRICA, South Korea, Sri Lanka, SWITZERLAND, TAIPEI, TAIWAN, Thailand, TUJUNGA, UNITED ARAB EMIRATES (UAE), URUGUAY, Venezuela, Vietnam, VIGNATE ITALY, WOODDALE, and Yemen.
Product codes and lots: Catalog number: 16405 and serial numbers: 1001-1466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24
Z-0127-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24
Z-0128-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24
Z-0129-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24
Z-0130-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24
Z-0131-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-24

Product code DTQ

K915183Class IISarns 8000 Modular Perfusion System3M Health Care, Sarns / cleared 1992-07-08

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)