Events

Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell 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
    60475
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0842-2012
  • 사례 시작날짜
    2010-06-28
  • 사례 출판 날짜
    2012-01-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105511
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • 원인
    Complaints were received of expired x-coated capiox sx18 hollow fiber oxygenators.
  • 조치
    All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed "Urgent Medical Device Removal " letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.

Device

Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell Reservoir
  • 모델명 / 제조번호(시리얼번호)
    Product code 3CXSX18RX, Lot # HF22
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including states of: WI, MO,and KY.
  • 제품 설명
    Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 ¿. 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.
  • 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