Events

Device Recall PREFACE 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
    36988
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0537-2007
  • 사례 시작날짜
    2006-11-17
  • 사례 출판 날짜
    2007-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49713
  • 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
    intravascular guiding sheath - Product Code DYB
  • 원인
    Biosense webster, inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the preface sheath during use in the left atrium.
  • 조치
    Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.

Device

Device Recall PREFACE
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 13070991,  13073870,  13073873,  13080117,  13082797 ,  13090941, 13099292,  13103566,  13109369, L0103032, L0103066, L0103069,  L0103295,  L0105007,  L0106017, L0106161,  L0106271, L0203066, L0206045, L0206152, L0206235,  L0206249, L0304237, L0306029,  L0306084, L0306161, L0306209, L0404116, L0502384, L0502568, L0504042,  L0602226, L0604089, L0704070, L0804173,  L0902370, L0902618, L0904056,  L0904071, L0904089, L0904134,  L0904150,  L1002219, L1004025, L1004057,  L1004259, L1102088, L1102219, L1205135 & L1205189
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • 제품 설명
    Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS
  • 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