Events

Device Recall CAPIOX Flexible Venous Reservoir 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular 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
    59454
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2950-2011
  • 사례 시작날짜
    2011-07-21
  • 사례 출판 날짜
    2011-08-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102828
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • 원인
    Reservoir blood bag used in cardiovascular procedures may leak.
  • 조치
    Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated July 20, 2011, to all affected consignee. The letter described the problem, the potential hazard, and the actions to be taken. The letter instructed customers to identify affected inventory and segregate from non-affected product. The recalling firm advises users to not use affected product and return for replacement. The customers are instructed to call the recalling firm Customer Service for a Returned Goods Authorization (RGA) number. Customers were asked to complete the attached Response Form and return as per the instructions. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM EST.

Device

Device Recall CAPIOX Flexible Venous Reservoir
  • 모델명 / 제조번호(시리얼번호)
    CAPIOX Flexible Venous Reservoir, Lot NE13, (used as single units) or as a component in sterilized custom cardiovascular procedure kits with kit lot numbers NC21 R, ND21 R, NF02, and NF02.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    (USA) Nationwide Distribution including states of: FL, MI, MT, NY, TN and VA.
  • 제품 설명
    CAPIOX¿ Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** || Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.
  • Manufacturer
    Terumo Cardiovascular Corporation

Manufacturer

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