Events

Device Recall Arterial Needles 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
    77273
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2252-2017
  • 사례 시작날짜
    2017-05-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155591
  • 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
    Saw, manual and accessories - Product Code GDR
  • 원인
    Argon medical has received a complaint from one of their distributors of a potential packaging defect. the product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
  • 조치
    Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form.

Device

Device Recall Arterial Needles
  • 모델명 / 제조번호(시리얼번호)
    11161099 11161729 11160990 11160912
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
  • 제품 설명
    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 || Usage: || Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc