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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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.
Recall Number Z-2218-2012
Classification Class III
Code Info catalog number: 16401 and serial number: 2001, 2002, and 2003.
Product Distributed Qty 3
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 March 2007 by replacing the incorrect label at the customer location. The action was not reported to FDA at that time.

Event Detail

Event Id 62732
Product Type Devices
Status Completed
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution - including the state of New York