BEUDAMED
    FDA Recall Terminated

    Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set.

    Recall: Z-1639-2010 · Initiated October 20, 2009

    Recall

    Recall Number
    Z-1639-2010
    Event Number
    54174
    Firm
    Churchill Medical Systems, Inc.
    FEI Number
    1000120555
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    October 20, 2009
    Posted
    May 21, 2010
    Terminated
    March 28, 2013
    Address
    87 Venture Drive, Dover, NH, 03820-5914

    Description

    Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set.

    Reason

    Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents

    Action

    Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.

    Distribution

    Distributed to Florida.

    Quantity

    283,900 each