Events

Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Mitek, Inc., a Johnson & Johnson Co. 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
    66145
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0192-2014
  • 사례 시작날짜
    2013-08-29
  • 사례 출판 날짜
    2013-11-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121553
  • 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
    Arthroscope - Product Code HRX
  • 원인
    Pillow valve included in the fms duo outflow tubing set and the fms solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the one day set which may potentially lead to patient cross-contamination.
  • 조치
    DePuy Mitek inititaed telephone notification on Ausgust 29, 2013 and sent an Urgent Voluntary Product Recall letter dated September 5, 2013 to US and OUS affected customers/affiliates. The customers were notified of the affected products, problem and actions to be taken. The customers were instructed to immediately check all inventories to locate and return affected product following the enclosed instructions. Stericycle is cooridianting the returns. If you have any questions or concerns in regards to this recall, please contact Stericycle directly at 1-866-737-1928.

Device

Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve
  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
  • 제품 설명
    DePuy Mitek FMS Outflow Tubing with One-Way valve || Product Code:284649 || Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • 제조사 주소
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA