Events

Device Recall SwanGanz CCO/Sv02/CEDV/VIP Thermodilution Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences, LLC 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
    71169
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1700-2015
  • 사례 시작날짜
    2015-05-05
  • 사례 출판 날짜
    2015-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136322
  • 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, flow directed - Product Code DYG
  • 원인
    The product failed to meet the internal established statistical test requirement for heparin activity.
  • 조치
    On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838

Device

Device Recall SwanGanz CCO/Sv02/CEDV/VIP Thermodilution Catheters
  • 모델명 / 제조번호(시리얼번호)
    lot number 59860969.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
  • 제품 설명
    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC