Events

Device Recall IPSAN patient bracelet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Laboratories, 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
    27748
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0229-04
  • 사례 시작날짜
    2003-11-18
  • 사례 출판 날짜
    2003-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30459
  • 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
    Gases Used Within Eye To Place Pressure On Detached Retina - Product Code LPO
  • 원인
    The firm initiated the recall on 11/18/2003 via letters to all consignees. the letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ispan gas administered who may still have a bubble present in the eye.
  • 조치
    The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, 'stickoxid', which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (grey) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).

Device

Device Recall IPSAN patient bracelet
  • 모델명 / 제조번호(시리얼번호)
    All lots of the German translated patient bracelets
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Germany, Switzerland, and Austria
  • 제품 설명
    ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • 제조사 주소
    Alcon Laboratories, Inc, 6600 South Fwy, Fort Worth TX 76134-2901
  • Source
    USFDA