Events

Device Recall Autoject E1 Fixed needle device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Owen Mumford USA, 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
    70665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1366-2015
  • 사례 시작날짜
    2014-11-24
  • 사례 출판 날짜
    2015-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134363
  • 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
    Introducer, syringe needle - Product Code KZH
  • 원인
    The syringe carrier is missing components: a damper and spring.
  • 조치
    Recall letters were issued to customers via FedEx. The letter instructed the customer to check their shelves for the product and specific lot number and to visually inspect (pictures included in letter of a correctly assembled device and one with the missing spring & damper) the device if they have the affected lot. A form was included which was to be filed out and returned.

Device

Device Recall Autoject E1 Fixed needle device
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 5LW
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
  • 제품 설명
    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 || The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
  • Manufacturer
    Owen Mumford USA, Inc.

Manufacturer

Owen Mumford USA, Inc.
  • 제조사 주소
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • 제조사 모회사 (2017)
    Owen Mumford Holdings Limited
  • Source
    USFDA