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.
FDA Recall Z-2218-2012 · Posted 2012-08-16
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2012-06-20
Date Terminated2012-11-07
Product Quantity3
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
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution - including the state of New York
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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