Z-2348-2012Class II

Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use...

Name: Z-2348-2012 Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2009-08-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2009-08-12 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation... on 2009-08-12. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2348-2012
Classification: Class II
Status: Terminated
Initiated: 2009-08-12
Posted: 2012-09-11
Terminated: 2013-01-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Safety monitor included with System 8000 Base 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. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 8
Distribution: Worldwide distribution: International only-country of: Terumo Dubai, UAE
Product codes and lots: catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11

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)