BEUDAMED
    FDA Recall Terminated

    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).

    Recall: Z-0407-2009 · Initiated August 22, 2008

    Recall

    Recall Number
    Z-0407-2009
    Event Number
    49522
    Firm
    Mentor Texas, Inc
    FEI Number
    1000118360
    Product Code
    GAZ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    August 22, 2008
    Posted
    December 12, 2008
    Terminated
    August 26, 2010
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500

    Description

    Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).

    Reason

    The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.

    Action

    Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.

    Distribution

    Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and South Africa.

    Quantity

    32,480 Aseptic Transfer Sets (4 syringes/set)