BEUDAMED
    FDA Recall Terminated

    Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%

    Recall: Z-0712-03 · Initiated February 25, 2003

    Recall

    Recall Number
    Z-0712-03
    Event Number
    25811
    Firm
    Sybron Dental Specialties
    FEI Number
    3001168737
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 25, 2003
    Posted
    April 9, 2003
    Terminated
    May 17, 2004
    Address
    1717 West Collins Avenue, Orange, CA, 92867

    Description

    Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%

    Reason

    Moisture ingress into packaging of test strips may cause premature failure.

    Action

    Notice was sent to customers of the potential problem on 3/7/2003. The notice included directions to perform a Modified Quality Control Procedure. Instructions are to test strips function each day.

    Distribution

    Nationwide and Canada.

    Quantity

    4,112 cases of two bottles each. 60 strips per bottle.