Events

Ethicon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 International Surgical Supply, 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
    27162
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1275-03
  • 사례 시작날짜
    2003-09-03
  • 사례 출판 날짜
    2003-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29378
  • 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
    Instrument, Surgical, Disposable - Product Code KDC
  • 원인
    Various sterile expired and non-expired ethicon brand surgical devices were resterilized without adequate validations and distributed.
  • 조치
    The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level.

Device

Ethicon
  • 모델명 / 제조번호(시리얼번호)
    all codes.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee.
  • 제품 설명
    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. || The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 || The product described on label is a: Needle, Ultra Veress.
  • Manufacturer
    International Surgical Supply, Inc.

Manufacturer

International Surgical Supply, Inc.
  • 제조사 주소
    International Surgical Supply, Inc., 8585 NW 72nd St., Miami FL 33166
  • Source
    USFDA