—#111539

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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915183
Affected lot / code info: catalog number: 16401 and serial number: 2001, 2002, and 2003.

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: US Nationwide Distribution - including the state of New York

Timeline

Recall initiated: 2012-06-20
Posted by FDA: 2012-08-16
Terminated: 2012-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.