Events

Device Recall EZ STEER Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biosense Webster, Inc. 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
    48179
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1647-2012
  • 사례 시작날짜
    2007-12-15
  • 사례 출판 날짜
    2012-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70961
  • 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, electrode recording, or probe, electrode recording - Product Code DRF
  • 원인
    The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
  • 조치
    The firm, Biosense Webster, sent a "Medical Device-Voluntary Field Removal" letter dated December 17, 2007 to its customer. The letter identified the product, problem and an action to be taken. The customer was instructed to complete and return the Product Voluntary Field Removal Certification Form via fax to Quality Compliance at (909) 839-7207or mail using the enclosed self-addressed stamped envelope. If you have additional questions, please follow up with your local Biosense Webster representative.or contact Customer Service at (909) 839-8500.

Device

Device Recall EZ STEER Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 13140790A
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA only.
  • 제품 설명
    EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter || Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • 제조사 주소
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA