Z-0738-04

Carbomedics VT-200 Valve Tester

Name: Z-0738-04 Carbomedics VT-200 Valve Tester
Creator: Carbomedics, Inc
Published: 2002-04-30
License: https://open.fda.gov/license/

Carbomedics, Inc. / initiated 2002-04-30 / Terminated / root cause: sterility

FDA source

Carbomedics, Inc began a recall of Carbomedics VT-200 Valve Tester on 2002-04-30. The reason FDA records is "Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0738-04
Status: Terminated
Initiated: 2002-04-30
Posted: 2004-07-20
Terminated: 2004-03-24
Recalling firm: Carbomedics, Inc.
Product: Carbomedics VT-200 Valve Tester
Product code: DTJ Holder, Heart-Valve, Prosthesis
Reason for recall: Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
Root cause tag: sterility
FDA 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 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
Product codes and lots: All lots

Product code DTJ

K960169Class ICarbomedics Valve TesterCarbomedics, Inc. / cleared 1996-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)