Vaxcel Implantable Chest Ports with PASV Valve Technology 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
    37442
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0630-2007
  • 사례 출판 날짜
    2007-03-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2007-11-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Implantable Vascular Access System - Product Code LJT
  • 원인
    Sterile barrier may have been compromised. firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
  • 조치
    On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lots 1137363, 1137364, 1137733, and 1137734
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,
  • Manufacturer

Manufacturer

  • 제조사 주소
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA