Events

Device Recall AORTIC ARCH CANNULA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group USA, Inc. 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
    74490
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2147-2016
  • 사례 시작날짜
    2016-06-22
  • 사례 출판 날짜
    2016-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147758
  • 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
    Sorin group usa is recalling aortic arch cannulae (part numbers na-55x7 and na-55x8) because the distal end may be less than specified. the defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
  • 조치
    The firm, LivaNova, sent an "Urgent Safety Alert" field communication letter dated June 22, 2016 via certified mail to consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: check your inventory to determine if you own Cannulae, if no inventory, complete the response form and return it per instructions indicated on form.; check the tip angle to determine if it is conforming to specifications, if specifications not met, file a complaint through your normal process whether you decide to keep it, use it or return it to Sorin Group; If you are not willing to use it, return affected product parts to Sorin Group USA,; contact Customer Service at 1-800-650-2623 or email CustomerService@livanova,com to have a RMA issued, and complete and return the Customer Response Form no later than July 20, 2016 via Fax at 303-467-6502 or by e-mail to USFSN@livanova.com. If you need support for the execution of these actions, please contact your LivaNova sales representative or call Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT). For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT) or e-mail USFSN@livanova.com.

Device

Device Recall AORTIC ARCH CANNULA
  • 모델명 / 제조번호(시리얼번호)
    Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ;
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
  • 제품 설명
    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) || Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA