Events

Device Recall Neptune waste management system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments, Instruments Div. 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
    25142
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0524-03
  • 사례 시작날짜
    2002-12-03
  • 사례 출판 날짜
    2003-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-07-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25290
  • 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
    Apparatus, Exhaust, Surgical - Product Code FYD
  • 원인
    Cap may be cracked and fail, exposing o.R. staff to patient blood, and cause an unexpected loud noise in the o.R.
  • 조치
    Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.

Device

Device Recall Neptune waste management system
  • 모델명 / 제조번호(시리얼번호)
    All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States
  • 제품 설명
    Stryker brand Neptune waste management system; model 711-27-1.
  • Manufacturer
    Stryker Instruments, Instruments Div.

Manufacturer

Stryker Instruments, Instruments Div.
  • 제조사 주소
    Stryker Instruments, Instruments Div., 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA