Events

Device Recall ENDOPATH Probe Plus II 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
    50510
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0657-2009
  • 사례 시작날짜
    2008-12-09
  • 사례 출판 날짜
    2009-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75702
  • 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
    Electrosurgery Probe - Product Code GCJ
  • 원인
    Nickel exposure: the stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. ethicon endo-surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens.
  • 조치
    On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.

Device

Device Recall ENDOPATH Probe Plus II
  • 모델명 / 제조번호(시리얼번호)
    Product Code EPS03 - Lot # E4K182, Exp. Date 2012-12; Lot # E4K59R, Exp. Date 2012-12; Lot # E4K67T, Exp. Date 2012-12; Lot # E4K81D, Exp. Date 2012-12; Lot # E4K938, Exp. Date 2012-12; Lot # D4JL20, Exp. Date 2012-09; Lot # D4JL21, Exp. Date 2012-09; Lot # D4JL22, Exp. Date 2012-09; Lot # E4KC1M, Exp. Date 2013-01; Lot # E4KF20, Exp. Date 2013-01; Lot # E4KK23, Exp. Date 2013-02; Lot # E4KK6V, Exp. Date 2013-02; Lot # E4KL0N, Exp. Date 2013-02; Lot # E4KR6Y, Exp. Date 2013-03; Lot # E4KV1X, Exp. Date 2013-03; Lot # E4KX2Z, Exp. Date 2013-03; Lot # E4KY5H, Exp. Date 2013-03; Lot # E4L18A, Exp. Date 2013-04; Lot # E4L404, Exp. Date 2013-04; Lot # E4L66M, Exp. Date 2013-04; Lot # E4L69A, Exp. Date 2013-05; Lot # E4L871, Exp. Date 2013-05; Lot # E4LA7Z, Exp. Date 2013-05; Lot # E4LD0T, Exp. Date 2013-05; Lot # E4LF5F, Exp. Date 2013-05; Lot # E4LJ46, Exp. Date 2013-06; Lot # E4LJ4F, Exp. Date 2013-06; Lot # E4LK9C, Exp. Date 2013-06; Lot # E4LN16, Exp. Date 2013-06; Lot # E4LP57, Exp. Date 2013-07; Lot # E4LR66, Exp. Date 2013-07; Lot # E4LT3Y, Exp. Date 2013-07; Lot # E4LU2Z, Exp. Date 2013-07; Lot # E4LV56, Exp. Date 2013-07; Lot # E4M00W, Exp. Date 2013-08; Lot # E4M01X, Exp. Date 2013-08; Lot # E4M120, Exp. Date 2013-08; Lot # E4M20L, Exp. Date 2013-08; Lot # E4M23R, Exp. Date 2013-08; Lot # E4M31A, Exp. Date 2013-08; Lot # E4M376, Exp. Date 2013-08; Lot # E4M39C, Exp. Date 2013-08; Lot # E4M572, Exp. Date 2013-08; Lot # E4M57U, Exp. Date 2013-08; Lot # E4M62M, Exp. Date 2013-08; Lot # E4M914, Exp. Date 2013-09; Lot # E4MA2R, Exp. Date 2013-09; and Lot # E4MD45, Exp. Date 2013-09
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.
  • 제품 설명
    Ethicon Endo-Surgery ENDOPATH¿ Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS03)
  • 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