Events

Device Recall Safedraw Venous Close Loop System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Argon Medical Devices, 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
    61832
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1946-2012
  • 사례 시작날짜
    2012-05-04
  • 사례 출판 날짜
    2012-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109201
  • 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
    Computer, blood pressure - Product Code DSK
  • 원인
    Some of the kits may exhibit a potential defect with the pouch seal. the pouch issue may compromise the sterile barrier.
  • 조치
    Argon Medical Devices sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Recall Response Form was attached to the letter for customers to complete and return to the firm via fax to 903-577-9393. Contact the firm at CRS@argonmedical.com for questions regarding this recall.

Device

Device Recall Safedraw Venous Close Loop System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 204889, Expiration Date March 2017
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Missouri.
  • 제품 설명
    Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. || The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc