Recall Z-0738-04 ยท DTJ Holder, Heart-Valve, Prosthesis
Carbomedics, Inc
Carbomedics VT-200 Valve Tester
| Date | Jul 20, 2004 (initiated Apr 30, 2002) |
| Status | Terminated |
| Reason | Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. |
| Root 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960169 | CARBOMEDICS VALVE TESTER Carbomedics, Inc., Apr 15, 1996 |