Events

Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems 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
    71196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1828-2015
  • 사례 시작날짜
    2015-05-06
  • 사례 출판 날짜
    2015-06-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136456
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • 원인
    The overpressure safety valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. it is intended for use only on the venous side. there is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
  • 조치
    Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.

Device

Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of MO and FL.
  • 제품 설명
    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. || For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA