Events

Device Recall Regard 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Resource Optimization & Innovation Llc 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
    76255
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1634-2017
  • 사례 시작날짜
    2017-01-09
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153119
  • 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
    General surgery tray - Product Code LRO
  • 원인
    Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
  • 조치
    ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.

Device

Device Recall Regard
  • 모델명 / 제조번호(시리얼번호)
    038092C Exp Date 2018-07-30; 039713C Exp Date 2018-08-30;
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to LA and TX.
  • 제품 설명
    Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B; - Medical Center Santa Rosa
  • Manufacturer
    Resource Optimization & Innovation Llc

Manufacturer

Resource Optimization & Innovation Llc
  • 제조사 주소
    Resource Optimization & Innovation Llc, 2909 N Neergard Ave, Springfield MO 65803-6317
  • Source
    USFDA