Date Initiated by Firm | October 21, 2011 |
Date Posted | November 29, 2011 |
Recall Status1 |
Terminated 3 on February 17, 2012 |
Recall Number | Z-0303-2012 |
Recall Event ID |
59479 |
510(K)Number | K915183 |
Product Classification |
Pump, blood, cardiopulmonary bypass, roller type - Product Code DWB
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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. |
Code Information |
Catalog Number 16422 Serial Number 1901 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | 734-741-6173 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
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 = DWB
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