Date Initiated by Firm | January 13, 2012 |
Date Posted | January 24, 2012 |
Recall Status1 |
Terminated 3 on December 03, 2012 |
Recall Number | Z-0839-2012 |
Recall Event ID |
60463 |
510(K)Number | K022947 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product | Roller Pump, 4 Inch Diameter
The Terumo Advanced Perfusion System 1 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 816570; Serial Numbers: 5939 - 5962 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | Tracy Bellanca 734-741-6056 |
Manufacturer Reason for Recall | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551. Roller pumps with affected cables will have the cables assembly replaced.
For questions regarding this recall call 1-800-521-2818. |
Quantity in Commerce | 44 |
Distribution | Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam |
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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