Events

Device Recall OmniPod Insulin Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Insulet Corporation 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
    72535
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0393-2016
  • 사례 시작날짜
    2015-11-02
  • 사례 출판 날짜
    2015-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141454
  • 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
    Pump, infusion, insulin - Product Code LZG
  • 원인
    Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
  • 조치
    Insulet issued on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.

Device

Device Recall OmniPod Insulin Management System
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • 제품 설명
    OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
    Insulet Corporation

Manufacturer

Insulet Corporation
  • 제조사 주소
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • 제조사 모회사 (2017)
    Insulet Corporation
  • Source
    USFDA