Events

Device Recall ARROWgard Blue YouBend TwoLumen Hemodialysis Catheterization Kit 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
    76937
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2308-2017
  • 사례 시작날짜
    2017-03-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155748
  • 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
    The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. it may be inserted into the jugular, subclavian, or femoral veins. the arrowg+ard blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. clinical data have not been collected that demonstrate the use of the arrowg+ard blue antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. the catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
  • 조치
    Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Device

Device Recall ARROWgard Blue YouBend TwoLumen Hemodialysis Catheterization Kit
  • 모델명 / 제조번호(시리얼번호)
    Material number CDA-22122-U1A
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions || The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA