Events

Rappel de Device Recall WANG Transbronchial Aspiration Needles

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ConMed Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63728
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0504-2013
  • Date de mise en oeuvre de l'événement
    2012-11-20
  • Date de publication de l'événement
    2012-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114677
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Bronchoscope (flexible or rigid) - Product Code EOQ
  • Cause
    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
  • Modèle / numéro de série
    Begining Lot 11207241, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210081. 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).
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal 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.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Adresse du fabricant
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA