Events

Device Recall Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit 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
    52189
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1626-2009
  • 사례 시작날짜
    2009-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82473
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • 원인
    The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
  • 조치
    Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.

Device

Device Recall Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit
  • 모델명 / 제조번호(시리얼번호)
    M00566490, Lot Numbers: 18893672, 11942231 and 12163810; and M00566491, Lot Numbers: 11934737 and 11996717.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • 제품 설명
    Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6649, inner pouch UPN M00566490 and outer carton UPN M00566491. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • 제조사 주소
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA