BEUDAMED
    FDA Recall Terminated

    Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.

    Recall: Z-1733-2009 · Initiated May 6, 2009

    Recall

    Recall Number
    Z-1733-2009
    Event Number
    52111
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JSY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 6, 2009
    Posted
    August 14, 2009
    Terminated
    October 15, 2009
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.

    Reason

    The plate labeling is incorrect, but the outer box labeling is correct

    Action

    The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.

    Distribution

    Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.

    Quantity

    118 packages