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Terminated

Carbomedics VT-200 Valve Tester

FDA Recall Z-0738-04 · Posted 2004-07-20

Recalling FirmCarbomedics, Inc
Recall StatusTerminated
Product CodeDTJ
Date Initiated2002-04-30
Date Terminated2004-03-24
Product Quantity4606 units

Reason for Recall

Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960169CARBOMEDICS VALVE TESTERCarbomedics, Inc. · 1996-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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