BEUDAMED
    FDA Enforcement Class II Terminated

    WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

    Recall: Z-0503-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0503-2013
    Event ID
    63728
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2012
    Initiation Date
    November 20, 2012
    Classification Date
    December 10, 2012
    Termination Date
    August 25, 2015
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.

    Reason

    ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.

    Code Info

    Beginning Lot Code 1209171, Ending Lot Code 1210101. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift Code (1, 2, 3, 4, 5, 6 or 9).

    Distribution

    Worldwide Distribution - USA including CA , FL, IA, IN, MA, MD, ME, MO, MS, NC, NM, OH, PA, TX. Foreign distribution to Spain, Portugal, Japan and Hungary.

    Quantity

    Total 452