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U.S. Department of Health and Human Services

Class 2 Device Recall 8K Cardioplegia Monitor

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  Class 2 Device Recall 8K Cardioplegia Monitor see related information
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
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/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
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

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.
510(K) Database 510(K)s with Product Code = DWB and Original Applicant = 3M HEALTH CARE, SARNS