Events

Device Recall Sarns 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
    61731
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1886-2012
  • 사례 시작날짜
    2012-05-09
  • 사례 출판 날짜
    2012-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108824
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    During production of the sarns antegrade cardioplegia cannula, terumo cardiovascular systems (terumo cvs) identified the presence of a foreign substance on the inner surface of some cannulae tips. terumo cvs' preliminary investigation found that the substance can be dislodged from the cannula surface. the substance was likely deposited during the molding process, but the exact composition of the.
  • 조치
    Terumo sent an Urgent Medical Device Recall letter dated May 9, 2012 to All US first consignees will receive a removal notification letter via Federal Express. The letter identified the affected products, reason for correction and actions to be taken. Customers were instructed to discontinue use of affected products and return for replacement. The letter advised customers to assure that all users are aware of this notice and to fill out and return the attached Response Form. For questions call Terumo CVS Customer Service at 1-800-521-2818 or by fax at 1-800-292-6551.

Device

Device Recall Sarns
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 74301 and lot number: PD19
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • 제품 설명
    X-COATED FX25RW H/L PACK || Product Usage: || The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA