Date Initiated by Firm | June 04, 2013 |
Date Posted | December 27, 2013 |
Recall Status1 |
Terminated 3 on October 01, 2014 |
Recall Number | Z-0603-2014 |
Recall Event ID |
67064 |
510(K)Number | K820297 |
Product Classification |
Valve, pressure relief, cardiopulmonary by Medical - Product Code MNJ
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Product | Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line |
Code Information |
N/A |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 125 Blue Ball Rd Elkton MD 21921-5315
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For Additional Information Contact | 410-392-7102 |
Manufacturer Reason for Recall | Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. |
FDA Determined Cause 2 | Component design/selection |
Action | Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818. |
Quantity in Commerce | 24,227. |
Distribution | Nationwide
Canada |
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 = MNJ
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