Events

Device Recall Autopen Classic 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
    70783
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2082-2015
  • 사례 시작날짜
    2014-12-11
  • 사례 출판 날짜
    2015-07-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134665
  • 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
    Syringe, piston - Product Code FMF
  • 원인
    The dials in the autopens are not working - the dial does not stay dialed, but springs right back to 0. as a result, the patient could not dial up a dose of medicine to deliver via an injection.
  • 조치
    Owen Mumford, Inc. sent an Urgent Medical Device Recall Notification letter dated December 19, 2014, to all affected customers via Fed Ex. The letter instructed customers to check their shelves for the product and specific lot number. The customer was instructed to contact Customer Service to obtain an RMA and a pre-paid, pre-addressed label for return of the devices. A form was included for the documentation of the inspection of their inventory, whether any are in stock and will be returned, and if they will provide a customer list of how they sold any devices to or that they will notify their customers of the issue with the product. They were instructed to fill it out and fax back to 770-977-2866. Customers with questions were instructed to contact Customer Service Department at 1-800-421-6936. For questions regarding this recall call 770-977-2226, ext 13.

Device

Device Recall Autopen Classic
  • 모델명 / 제조번호(시리얼번호)
    Lot 7JH, UPC Code 384703800014
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
  • 제품 설명
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, || The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
  • 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