BEUDAMED
    FDA Recall Terminated

    Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)

    Recall: Z-2428-2010 · Initiated August 16, 2010

    Recall

    Recall Number
    Z-2428-2010
    Event Number
    56564
    Firm
    BioMed Laboratories
    FEI Number
    3006784948
    Product Code
    GDS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 16, 2010
    Posted
    September 17, 2010
    Terminated
    January 24, 2011
    Address
    2414 Executive Dr, # 102, Garland, TX, 75041-6123

    Description

    Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)

    Reason

    The product may contain the mold Aspergillus ssp.

    Action

    Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.

    Distribution

    OH, FL, MI

    Quantity

    22,253 (18,060 8oz bottles. 4,193 1oz bottles)