Events

Device Recall WANG Transbronchial Aspiration Needles 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    63728
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0503-2013
  • 사례 시작날짜
    2012-11-20
  • 사례 출판 날짜
    2012-12-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114676
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Bronchoscope (flexible or rigid) - Product Code EOQ
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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).
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA