BEUDAMED
    FDA Enforcement Class II Terminated

    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

    Recall: Z-0113-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0113-2015
    Event ID
    69204
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 29, 2014
    Initiation Date
    August 28, 2014
    Classification Date
    October 22, 2014
    Termination Date
    March 30, 2015
    Address
    2750 Morris Rd Ste A200, Lansdale, PA, 19446-6083, United States

    Description

    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

    Reason

    Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

    Code Info

    Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.

    Distribution

    Worldwide Distribution - US including CA and Internationally to CA.

    Quantity

    42250