BEUDAMED
    FDA Recall Terminated

    Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.

    Recall: Z-0815-2012 · Initiated December 20, 2011

    Recall

    Recall Number
    Z-0815-2012
    Event Number
    60897
    Firm
    Mallinckrodt Inc
    FEI Number
    1518293
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 20, 2011
    Posted
    January 19, 2012
    Terminated
    February 19, 2013
    Address
    2111 E Galbraith Rd, Cincinnati, OH, 45237-1624

    Description

    Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.

    Reason

    The firm received complaints from their customers stating that they found open seals on two of their sterilized products.

    Action

    Mallinckrodt Inc. sent an "URGENT DEVICE RECALL" letter dated December 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product and to complete and return an attached Business Response form via fax to (314) 654-8206 or e-mail to [email protected]. Contact the Product Monitoring Department at 800-778-7898 for questions regarding this notice.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of AZ, CA, GA, IA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, WA, WI and WV and countries of Australia, Belgium, Canada, Japan and Singapore.

    Quantity

    63,900 units