Events

ENDOPATHETSFlex Endoscopic Linear Cutter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon Endo-Surgery Inc 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
    48604
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2161-2008
  • 사례 시작날짜
    2008-04-24
  • 사례 출판 날짜
    2008-08-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71707
  • 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
    Surgical Cutter - Product Code FZT
  • 원인
    The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
  • 조치
    Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.

Device

ENDOPATHETSFlex Endoscopic Linear Cutter
  • 모델명 / 제조번호(시리얼번호)
    Batch #s: D4G751, D4G753, D4G80W, D4G84U, D4G85N, D4G983, D4GA5T, D4GA5U, D4GD6D, D4GE7U, D4GE7V, D4GH0X, D4GH8E, D4GK3M, D4GL0U, D4GN0F, D4GN0G, D4GN1C, D4GN85, D4GN86, D4GP7U, D4GP7V, D4GT3X, D4GT3Y, D4GW1U, D4GW1V, D4GW2H, D4GW3G, D4GW8H, D4H037, D4H038, D4H07L, D4H07M, D4H213, D4H214, D4H546, D4H55J, D4H61E, D4H61F, D4H66D, D4H66E, D4H804, D4H806, D4H80W, D4H80X, D4H82E, D4H86F, D4H91Z, D4H97U, D4H98J, D4H98K, D4HA2X, D4HA54, D4HC1X, D4HC1Y, D4HC93, D4HC94, D4HD95, D4HD96, D4HE2D, D4HE2E, D4HF2F, D4HF2G, D4HG65, D4HG66, D4HJ0A, D4HJ8R, D4HJ9K, D4HK2G, D4HK4G, D4HL5M, D4HL6K, D4HM2L, D4HM2N, D4HM7W, D4HN1Y, D4HN1Z, D4HN5E, D4HR1L, D4HR1M, D4HT53, D4HT5K, D4HU3W, D4HU3X, D4HU79, D4HV1P, D4HV3C, D4HV3D, D4HW0G, D4HW1A, D4HY9R, D4HZ86, D4J14K, D4J198, D4J199, D4J91, D4JC0, and D4JC9P
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
  • 제품 설명
    ENDOPATH¿ETS-Flex Endoscopic Linear Cutter, ATW35 || Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA