Events

OMRIX 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. 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
    29728
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1497-04
  • 사례 시작날짜
    2004-08-06
  • 사례 출판 날짜
    2004-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34432
  • 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
    Syringe, Piston - Product Code FMF
  • 원인
    5 ml crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
  • 조치
    American Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004.

Device

OMRIX
  • 모델명 / 제조번호(시리얼번호)
    Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped from Israel to the American Red Cross distribution center in Louisville, KY. From there, the ARC would ship the product to other distributors and/or directly to 46 hospitals nationwide. There are no govt accounts.
  • 제품 설명
    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC || 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
  • Manufacturer
    Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.

Manufacturer

Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
  • 제조사 주소
    Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst., Magen David Adom Blood Services Ctr.,, Sheba Hospital, Ramat Gan Israel
  • Source
    USFDA