BEUDAMED
    FDA Recall Terminated

    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids

    Recall: Z-1471-2015 · Initiated January 15, 2015

    Recall

    Recall Number
    Z-1471-2015
    Event Number
    70369
    Firm
    Churchill Medical Systems, Inc.
    FEI Number
    1000120555
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 15, 2015
    Posted
    April 21, 2015
    Terminated
    February 25, 2016
    Address
    87 Venture Drive, Dover, NH, 03820-5914

    Description

    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids

    Reason

    Potential for leaking caused by insufficient bond between needleless device and female luer.

    Action

    Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at [email protected].

    Distribution

    Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

    Quantity

    450