BEUDAMED
    FDA Enforcement Class II Terminated

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    Recall: Z-0068-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0068-2017
    Event ID
    75273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Surgical Specialties Mexico S DE RL DE CV
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    September 24, 2016
    Classification Date
    October 11, 2016
    Termination Date
    December 6, 2016
    Address
    Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana, N/A, N/A, Mexico

    Description

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    Reason

    Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

    Code Info

    MAWX380, MAZD460, MAZR350, MBCF540

    Distribution

    US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT. Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,

    Quantity

    512 boxes (2560 units)