FDA Medical Device Recalls (openFDA)
Carbomedics, Inc: Carbomedics VT-200 Valve Tester
- Recall number
- Z-0738-04
- Recalling firm
- Carbomedics, Inc
- Product
- Carbomedics VT-200 Valve Tester
- Status
- Terminated
- Initiated
- 2002-04-30
- Posted
- 2004-07-20
- Terminated
- 2004-03-24
- 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
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K960169"]
- PMA numbers
- not on file
- Product code
- DTJ
- Firm FEI
- 1627803
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28