Events

Device Recall OPHTHALMIC DRS TRAY 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Centurion Medical Products 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
    76730
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1732-2017
  • 사례 시작날짜
    2017-03-09
  • 사례 출판 날짜
    2017-03-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154050
  • 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
    Dressing change tray - Product Code OXQ
  • 원인
    Centurion medical products is recalling convenience kits that contain covidien curity oval eye pads due to supplier's recall because of potential breach in sterile packaging.
  • 조치
    On March 9, 2017 Centurion Medical Products recalled specific lots of medical convenience kits due to a supplier initiated recall of Covidien Curity Eye Pads. All affected customers were notified, advised to discontinue use of associated kits, and requested to confirm the status of remaining stock to Centurion.

Device

Device Recall OPHTHALMIC DRS TRAY
  • 모델명 / 제조번호(시리얼번호)
    Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016081550 4/30/19 2016080950 4/30/19 2016072250 12/31/18 2016051350 10/31/18 2016030550 4/30/18 2016022350 4/30/18 2016011850 4/30/18 2015122150 4/30/18 2015121450 4/30/18 2015101250 4/30/18 2015070750 2/28/18 2015062950 2/28/18 2015061950 1/31/18 2015062250 2/28/18 2015051850 1/31/18 2015050450 2/28/18 2015042850 11/30/17 2015031950 11/30/17 2015010750 10/31/17 2014103150 7/31/17 2014102750 7/31/17 2014073050 5/31/17
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
  • 제품 설명
    OPHTHALMIC DRS TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • 제조사 주소
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA