Events

Device Recall Vaxcel PICC with PASV Valve Technology 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 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
    30572
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0403-05
  • 사례 시작날짜
    2004-11-22
  • 사례 출판 날짜
    2005-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-12-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36139
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • 원인
    Catheter separation immediately distal to the nose of the suture wing.
  • 조치
    Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.

Device

Device Recall Vaxcel PICC with PASV Valve Technology
  • 모델명 / 제조번호(시리얼번호)
    913404; 913661; 917962; 924521; 930616; 936038; 943745; 950540; 950969; 3010403046; 3010403102; 3010803014; 3010803015; 3010803016; 3010803178; 3011002259; 3011102034; 3011102035;
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY ''. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA