BEUDAMED
    FDA Recall Terminated

    Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit

    Recall: Z-1015-2011 · Initiated December 6, 2010

    Recall

    Recall Number
    Z-1015-2011
    Event Number
    57661
    Firm
    Centurion Medical Products
    FEI Number
    1824619
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2010
    Posted
    February 1, 2011
    Terminated
    February 16, 2011
    Address
    301 Catrell Dr, Howell, MI, 48843-1703

    Description

    Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit

    Reason

    The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)".

    Action

    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: [email protected]. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: [email protected] or fax: 302-822-6009.

    Distribution

    Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.

    Quantity

    140 kits