| Class 2 Device Recall 8K Cardioplegia Monitor | |
Date Initiated by Firm | August 29, 2011 |
Date Posted | September 15, 2011 |
Recall Status1 |
Terminated 3 on March 08, 2013 |
Recall Number | Z-3214-2011 |
Recall Event ID |
59528 |
510(K)Number | K960916 |
Product Classification |
Pump, blood, cardiopulmonary bypass, roller type - Product Code DWB
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Product | Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373
The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. |
Code Information |
Cardioplegia Catalog Number 16414 and Serial Numbers 2060, 3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904, 3906-3913, 3915-3933 and 3935. Also, catalog number 816373, Serial numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688, 514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503, 557425, 563225, 568962 and 576045. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | 800-521-2818 |
Manufacturer Reason for Recall | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. |
FDA Determined Cause 2 | Component change control |
Action | Terumo Cardiovascular Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 29, 2011 to all affected customers. The letter describes the product, problem, and action to be taken.
The letter advises customers to make sure all users are aware of the notice. Customers are instructed to complete and return an attached Customer Response Form. Terumo will replace the software on all monitors of the affected product.
Customers with questions or concerns should call Terumo CVS Customer Service 1-800-521-2818. |
Quantity in Commerce | 85 |
Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, AR, CA, CO, GA, IL, IN, MS, NC, OH, TN, VA, and WI and countries of Belgium, Columbia, Hong Kong, India, Singapore, and Taiwan. |
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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