Carbomedics VT-200 Valve Tester
FDA device recall Z-0738-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Carbomedics, Inc
- Reason for recall
- Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTJ
- Quantity affected
- 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,
- Date initiated
- 2002-04-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-24
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARBOMEDICS VALVE TESTER (K960169) | Carbomedics, Inc. | 1996-04-15 |