Events

Device Recall Stabilizer, Heart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    76346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1232-2017
  • 사례 시작날짜
    2015-01-05
  • 사례 출판 날짜
    2017-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152937
  • 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
    stabilizer,heart - Product Code MWS
  • 원인
    Terumo cardiovascular systems (terumo cvs) is voluntarily recalling certain lots of titan" stabilizers and titan" 360 stabilizers because the suction tubing clip may break when it is being attached to a terumo cvs hercules stabilizing arm. although the clip is for convenience purposes and is not required for device operation, there is a potential for broken suction tubing clip fragments to fall into the surgical site.
  • 조치
    A recall notification is being forwarded to all users and consignees who have received product. The notification of this voluntary recall will be sent to the following consignee in each facility:+ Director of Operating Room Services Proposed Level of Effectiveness Checks: Terumo CVS will verify that 100% of all letters are delivered to affected consignees

Device

Device Recall Stabilizer, Heart
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R   Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
  • 제품 설명
    Titan" Stabilizer Attachment and Titan TM 360 Stabilizer || Attachment
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA