Events

Prostate Seeding Needle, Applicator Technique 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Worldwide Medical Technologies, LLC 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
    59712
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0040-2012
  • 사례 시작날짜
    2011-08-12
  • 사례 출판 날짜
    2011-10-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103394
  • 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
    Manual Radionuclide Applicator System - Product Code IWJ
  • 원인
    Length of the cannula hub is longer and may not permit a fit with the applicator.
  • 조치
    BrachySciences, a division of Biocompatibles, Inc., sent out "Urgent Recall Device Recall" letters Dated August 12, 2011 to all affected customers. The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm. For questions on this recall contact the firm at (203) 262-0571, extension 105.

Device

Prostate Seeding Needle, Applicator Technique
  • 모델명 / 제조번호(시리얼번호)
    Product code PSS1820AT Lot 116261, Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide distribution including the states of AR, CO, DE. FL, KY, MD, MI, MN, NY, TX, and VA; and the countries of Belgium, and Germany.
  • 제품 설명
    Prostrate Seeding Applicator Needle. Product code PSS1820AT || Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. || Worldwide Medical Technologies, LLC || Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate
  • Manufacturer
    Worldwide Medical Technologies, LLC

Manufacturer

Worldwide Medical Technologies, LLC