BEUDAMED
    FDA Recall Terminated

    Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.

    Recall: Z-1532-2010 · Initiated July 15, 2009

    Recall

    Recall Number
    Z-1532-2010
    Event Number
    52777
    Firm
    Steritec Products Mfc. Co., Inc.
    FEI Number
    1000125215
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2009
    Posted
    April 29, 2010
    Terminated
    June 28, 2010
    Address
    74 Inverness Dr E, Englewood, CO, 80112-5114

    Description

    Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.

    Reason

    This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling.

    Action

    Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.

    Distribution

    Nationwide distribution: IL, MI, NY, OH, VA

    Quantity

    63 cases