Events

Device Recall Arrow Internationa IABP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    64527
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1064-2013
  • 사례 시작날짜
    2012-11-27
  • 사례 출판 날짜
    2013-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116403
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • 원인
    Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
  • 조치
    Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.

Device

Device Recall Arrow Internationa IABP
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: KF2073734  KS2083999  KF2083869 KF2083921
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
  • 제품 설명
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; || Product Number: IAB-05830-LWS. || The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA