Device Recall Profiler Balloon Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Worldwide Headquarters 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
    59831
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3262-2011
  • 사례 시작날짜
    2011-02-25
  • 사례 출판 날짜
    2011-09-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-10-18
  • 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
    Percutaneous Catheter - Product Code DQY
  • 원인
    The particular lots of profiler pta balloon catheters were labeled incorrectly. lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.
  • 조치
    Angiodynamics, Inc sent a "Urgent Medical Device Recall letter" dated February 25, 2011 to all affected customers via Certified Mail Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following steps 1. Identify and segregate the recalled lot that is in your possession. 2. Complete the enclosed Profiler PTA Balloon Catheter Recall Reply Form and fax it to the attention of the Profiler PTA Balloon Catheter Recall Coordinator at 518-798-1360. The form lists the catalog numbers, lot numbers, and quantity our records indicate your facility has received. For further questions please call 1-800-772-6446.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 532794 (Use By 2013-12)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.
  • 제품 설명
    ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 || Cardiovascular catheterization
  • Manufacturer

Manufacturer

  • 제조사 주소
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • 제조사 모회사 (2017)
  • Source
    USFDA