Class 2 Device Recall Carbomedics

• Date Initiated by Firm: April 30, 2002
• Date Posted: July 20, 2004
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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