Events

Device Recall TwoLumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWgard Blue PLUS (R) Cathe 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
    53954
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0786-2010
  • 사례 시작날짜
    2009-11-24
  • 사례 출판 날짜
    2010-03-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86934
  • 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, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
  • 원인
    Q-syte component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
  • 조치
    The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.

Device

Device Recall TwoLumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWgard Blue P...
  • 모델명 / 제조번호(시리얼번호)
    Product number ASK-42802-SHB. Lot numbers RF9068926
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were shipped to distributors in GA, MD, and VA.
  • 제품 설명
    Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte)
  • 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