Events

Device Recall TheraSphere 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MDS Canada Inc. DBA MDS Nordion 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
    51701
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1325-2009
  • 사례 시작날짜
    2009-02-24
  • 사례 출판 날짜
    2009-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81031
  • 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
    microspheres radionuclide - Product Code NAW
  • 원인
    Instructions for the use of the pinch clamp that is an integral part of the therasphere administration set were not included with the distribution of the device.
  • 조치
    A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions. For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.com.

Device

Device Recall TheraSphere
  • 모델명 / 제조번호(시리얼번호)
    Package Insert Number K120615-023, Rev 9.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.
  • 제품 설명
    TheraSphere Administration Set (Part Number K125914-034). || TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
  • Manufacturer
    MDS Canada Inc. DBA MDS Nordion

Manufacturer

MDS Canada Inc. DBA MDS Nordion
  • 제조사 주소
    MDS Canada Inc. DBA MDS Nordion, 447 March Road, Ottawa Canada Ontario
  • 제조사 모회사 (2017)
    Nordion (Canada) Inc
  • Source
    USFDA