Events

Device Recall Catheter, Intravascular 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
    74898
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2771-2016
  • 사례 시작날짜
    2016-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148710
  • 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,long-term greater than 30 days - Product Code LJS
  • 원인
    Notification of component molding abnormality by supplier used to package certain arrow select kit (ask) products.
  • 조치
    The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com, even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Catheter, Intravascular
  • 모델명 / 제조번호(시리얼번호)
    Lot/Batch Numbers:  23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to states of: NC, OH, FL, and MD.
  • 제품 설명
    Cather, Ultrasound, Intravascular || The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
  • 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