BEUDAMED
    FDA Recall Terminated

    Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China

    Recall: Z-0777-06 · Initiated March 30, 2006

    Recall

    Recall Number
    Z-0777-06
    Event Number
    35123
    Firm
    Medline Industries, Inc.
    FEI Number
    3000717925
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2006
    Posted
    April 19, 2006
    Terminated
    May 9, 2006
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China

    Reason

    The product may not be sterile. The pouches were damaged during sterilization.

    Action

    The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.

    Distribution

    Texas

    Quantity

    21 cases