Events

Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carefusion 2200 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
    74647
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2847-2016
  • 사례 시작날짜
    2016-06-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148844
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • 원인
    The oral airway pouch within the pink/red oxygen delivery module, 7700raw, was incorrectly packaged with the 8 cm berman oral airway. the pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm berman oral airway component. therefore, the component within the pouch is incorrect. the pink/red oxygen delivery module, 7700raw, is intended to be used within the pink/red pouch of the broselow pediatric safety system. three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the pink/red oxygen delivery module, 7700raw, are affected by this voluntary field safety corrective action.
  • 조치
    Recall notices were sent 6/29/2016.

Device

Device Recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Illinois
  • 제품 설명
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc