Events

Recall of Device Recall WANG Transbronchial Aspiration Needles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConMed Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63728
  • Event Risk Class
    Class 2
  • Event Number
    Z-0502-2013
  • Event Initiated Date
    2012-11-20
  • Event Date Posted
    2012-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114653
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bronchoscope (flexible or rigid) - Product Code EOQ
  • 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.

Device

Device Recall WANG Transbronchial Aspiration Needles
  • Model / Serial
    Begining Lot 1207251, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210151. 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).
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral 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.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA