BEUDAMED
    FDA Recall Terminated

    Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486

    Recall: Z-0268-2007 · Initiated November 21, 2006

    Recall

    Recall Number
    Z-0268-2007
    Event Number
    36919
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2006
    Posted
    December 14, 2006
    Terminated
    January 31, 2008
    Address
    1 Medline Pl, Mundelein, IL, 60060-4486

    Description

    Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486

    Reason

    The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

    Action

    On 11/21/06, Medline telephoned the accounts who may have received the recalled lots, informing them that the skin scrub trays may not have gone through the full manufacturing cycle and are not sterile. They were requested to check their inventories for the two affected lots, removing any found from inventory and placing it on hold for return to Medline. The accounts were then sent a recall letter via fax on the same date, reiterating the telephone calls, and requesting the accounts to complete and fax back the attached response form, indicating amount of each lot placed on hold. Any questions were directed to Medline''s recall hotline at 866-359-1704.

    Distribution

    Minnesota, Illinois, Wisconsin and Indiana

    Quantity

    47 cases