Events

Cook Medical Ciaglia Blue Dolphin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cook, 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
    56084
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2078-2010
  • 사례 시작날짜
    2010-04-21
  • 사례 출판 날짜
    2010-07-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92611
  • 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
    Percutaneous Tracheostomy Introducer Set - Product Code JOH
  • 원인
    These set and/or tray products are being recalled because they include a covidien shiley 6perc or covidien shiley 8perc tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.
  • 조치
    Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.

Device

Cook Medical Ciaglia Blue Dolphin
  • 모델명 / 제조번호(시리얼번호)
    2381089, 2363190, 2283511, 2446534, 2308510, 2336319, 2344944, 2246874, 2306756, 2270536, 2279399, 2376120, 2319681, 2451345, 2283509, 2458351, 2458349, 2260717, 2368617, 2252379, 2283510, 2404347, 2308511, 2336318, 2446535, 2270537, 2279398, 2252380, 2344945, 2378606, 2376119, 2244980, 2319682, 2242060, 2451346, 2244979, and 2260716.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay.
  • 제품 설명
    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6, G13165.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • 제조사 주소
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA