Z-2218-2012Class III

System 8000 Base

Name: Z-2218-2012 System 8000 Base
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-06-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-06-20 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for... on 2012-06-20. FDA classified it as Class III and gives the reason as "During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating...". 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-2218-2012
Classification: Class III
Status: Terminated
Initiated: 2012-06-20
Posted: 2012-08-16
Terminated: 2012-11-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: System 8000 Base Product Usage: 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: During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.
Quantity in commerce: 3
Distribution: US Nationwide Distribution - including the state of New York
Product codes and lots: catalog number: 16401 and serial number: 2001, 2002, and 2003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2218-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16

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)