Z-0303-2012

Battery Module for Sarns Modular Perfusion System 8000

Name: Z-0303-2012 Battery Module for Sarns Modular Perfusion System 8000
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-10-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-10-21 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in... on 2011-10-21. The reason FDA records is "Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled...". 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-0303-2012
Status: Terminated
Initiated: 2011-10-21
Posted: 2011-11-29
Terminated: 2012-02-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
Product code: DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Reason for recall: Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution (USA) including the state of San Antonio, TX
Product codes and lots: Catalog Number 16422 Serial Number 1901

Product code DWB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)