BEUDAMED
    FDA Recall 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 · Initiated September 24, 2016

    Recall

    Recall Number
    Z-0068-2017
    Event Number
    75273
    Firm
    Surgical Specialties Mexico S DE RL DE CV Corredor Tijuana Rosarito 2000-24702 B Ejido Francisco Villa Tijuana Mexico
    FEI Number
    3010692967
    Product Code
    OMT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 24, 2016
    Terminated
    December 6, 2016

    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.

    Action

    An Urgent Product Recall Notification Letter dated 9/24/16 was sent to customers to inform them that Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package. The letter informs the customers to complete the customer acknowledgement form and return via fax to their quality assurance department at (610) 404-4010 or return via email to [email protected]. Customers with questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

    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)