Events

Device Recall Arrow International, Inc. Intraaortic balloon catheter 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
    51080
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1214-2009
  • 사례 시작날짜
    2009-02-02
  • 사례 출판 날짜
    2009-04-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78470
  • 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
    Intra-aortic balloon and control system - Product Code DSP
  • 원인
    A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on iabp model) rather than the appropriate 30, 40, or 50 cc volume.
  • 조치
    An "Urgent Medical Device Recall" letter dated February 2, 2009 was issued to consignees via US Certified Mail to notify users of the problem. Users were instructed to check their inventory for the affected products, quarantine, and return the them to Arrow International, Inc. Customers were also instructed to follow the "Mitigation Directions" in circumstances where alternate Intra-Aortic Balloon (IAB) catheters/adaptors or other forms of therapy are not available (until receipt of available product). Canadian accounts were notified on February 9, 2009 by courier and International accounts notified on 6 February 2009 and 10 February 2009 via Registered Post/UPS. Direct questions to your local Sales Representative or the Arrow International Customer Service at 1-800-523-8446 (US) or 1-919-361-4062 (outside US). Press Release issued April 13, 2009 is posted to firm's webiste: http://www.arrowintl.com/iab_recall.asp.

Device

Device Recall Arrow International, Inc. Intraaortic balloon catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial Numbers:  MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
  • 제품 설명
    7.5 Fr 30cc UltraFlex IAB, || IAB-06830-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
  • Manufacturer
    Arrow International, Inc.

Manufacturer

Arrow International, Inc.
  • 제조사 주소
    Arrow International, Inc., 9 Plymouth St, Everett MA 02149-1814
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA