Events

Device Recall Regard Custom Surgical Pack 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
    72053
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0229-2016
  • 사례 시작날짜
    2015-08-25
  • 사례 출판 날짜
    2015-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139676
  • 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 (kit) - Product Code LRO
  • 원인
    The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated iv set.
  • 조치
    ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory. For questions regarding this recall call 417-820-2793.

Device

Device Recall Regard Custom Surgical Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot 25787E, exp. date 1/19/2017
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to one customer in Oklahoma.
  • 제품 설명
    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
  • Manufacturer
    Resource Optimization & Innovation Llc

Manufacturer

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