Events

The Greenfield Vena Cava Filter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Scimed 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
    32889
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0300-06
  • 사례 시작날짜
    2005-08-05
  • 사례 출판 날짜
    2005-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41033
  • 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
    Filter, Intravascular, Cardiovascular - Product Code DTK
  • 원인
    Certain units within eleven lots of the 12 fr greenfield vena cava filter may lack a taper on the braided sheath of the delivery system. the lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.
  • 조치
    Urgent Recall Notice dated 08/04/05 was Federal Express''d to customers for delivery on 08/05/05. This notice informs customers of the issue and identifies affected product. Customers are asked to immediately discontinue use of and segregate these recalled lots. Steps for Voluntary Recall and Tracking/Verification Form were sent to the Risk Manager only. The Tracking/Verification Form is to be completed by the Risk Manager even if there are no affected lots to return. To return affected product, the customer must call Boston Scientific Corporation (BSC) to obtain a Returned Goods Authorization (RGA) number. Returned Goods are to be packaged and sent to BSC with the Tracking/Verification Form and using the enclosed red/white field action return shipping label to: Boston Scientific Marina Bay, 500 Commander Shea Blvd., Quincy, MA 02171

Device

The Greenfield Vena Cava Filter
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 7129578 and 7124116
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
  • 제품 설명
    Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • 제조사 주소
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA