BEUDAMED
    FDA Recall Terminated

    WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 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-0505-2013 · Initiated November 20, 2012

    Recall

    Recall Number
    Z-0505-2013
    Event Number
    63728
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    EOQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 20, 2012
    Posted
    December 10, 2012
    Terminated
    August 25, 2015
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 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.

    Action

    ConMed Corporation sent an Urgent Field Safety Notice letter dated November 30, 2012 with Response Form , to all affected customers via USPS Priority Mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete Attachment II and return it with any unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502 United Sates of America For information regarding this recall call 315-624-3225.

    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