Events

NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corp 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
    32288
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1393-05
  • 사례 시작날짜
    2004-05-05
  • 사례 출판 날짜
    2005-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-08-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39523
  • 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
    Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
  • 원인
    Molded handles used in angiographic manifolds may be occluded.
  • 조치
    Letters dated 5/4/2004 to Risk Managers with instructions to return product.

Device

NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of S...
  • 모델명 / 제조번호(시리얼번호)
    (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
  • 제품 설명
    NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • 제조사 주소
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA