BEUDAMED
    FDA Recall Terminated

    NeoMedical Incorporated, V -Cath Insertion Tray, REF301-00, Sterile.

    Recall: Z-1079-2011 · Initiated June 2, 2010

    Recall

    Recall Number
    Z-1079-2011
    Event Number
    56391
    Firm
    Centurion Medical Products
    FEI Number
    1824619
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 2, 2010
    Posted
    February 9, 2011
    Terminated
    February 9, 2011
    Address
    301 Catrell Dr, Howell, MI, 48843-1703

    Description

    NeoMedical Incorporated, V -Cath Insertion Tray, REF301-00, Sterile.

    Reason

    The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.

    Action

    Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.

    Distribution

    Nationwide distribution.

    Quantity

    420