Events

Device Recall Dual Lumen Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 OriGen Biomedical, 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
    70988
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1456-2015
  • 사례 시작날짜
    2015-03-30
  • 사례 출판 날짜
    2015-04-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135794
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
  • 조치
    The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product to OriGen Biomedical; and complete and return the attached acknowledgement and receipt form even if you do not currently have product in your inventory. The firm recommends that the consignee use an alternate product in the interim. If you have any questions regarding the return of product that you have on hand or the status of the investigation, please do not hesitate to conact the company at: OriGen Biomedical, Attn: Director, Quality and Regulatory Affairs, 7000 Burleson Rd, Bldg D, Austin, TX 78744 or call +1 512 474 7278 CST Monday-Friday 8:00-5:00.

Device

Device Recall Dual Lumen Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot N18549
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
  • 제품 설명
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. || OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
  • Manufacturer
    OriGen Biomedical, Inc.

Manufacturer

OriGen Biomedical, Inc.
  • 제조사 주소
    OriGen Biomedical, Inc., 7000 Burleson Rd, Bldg D, Austin TX 78744-3202
  • 제조사 모회사 (2017)
    Origen Biomedical Inc.
  • Source
    USFDA