Date Initiated by Firm | June 20, 2012 |
Date Posted | August 16, 2012 |
Recall Status1 |
Terminated 3 on November 07, 2012 |
Recall Number | Z-2218-2012 |
Recall Event ID |
62732 |
510(K)Number | K915183 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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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. |
Code Information |
catalog number: 16401 and serial number: 2001, 2002, and 2003. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
|
For Additional Information Contact | 734-741-6173 |
Manufacturer 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 |
FDA Determined Cause 2 | Labeling mix-ups |
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. |
Quantity in Commerce | 3 |
Distribution | US Nationwide Distribution - including the state of New York |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DTQ
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