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U.S. Department of Health and Human Services

Class 2 Device Recall Carbomedics

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  Class 2 Device Recall Carbomedics see related information
Date Initiated by Firm April 30, 2002
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 24, 2004
Recall Number Z-0738-04
Recall Event ID 28335
510(K)Number K960169  
Product Classification Holder, Heart-Valve, Prosthesis - Product Code DTJ
Product Carbomedics VT-200 Valve Tester
Code Information All lots
Recalling Firm/
Carbomedics, Inc
1300 E Anderson Ln
Austin TX 78752-1708
Manufacturer Reason
for Recall
Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
FDA Determined
Cause 2
Action Letters were sent to surgeons and hospital operating room supervisors in mid-May 2002 which included the following information: It is imperative that hospitals regularly and thoroughly inspect all testing instruments for indications of wear and degredation. And, CarboMedics is in the process of re-issuing suggested maintenance and sterilization guidlines.
Quantity in Commerce 4606 units
Distribution US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal, Ecuador, India, Japan, Hong Kong, Italy, Sweden, Belgium, Norway, Argentina, Spain, Malta, Austria, Switzerland, Netherlands, Germany, Australia, Finland
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 = DTJ and Original Applicant = CARBOMEDICS, INC.