Events

Device Recall EpiFLO SD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ogenix Corporation 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
    36130
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1526-06
  • 사례 시작날짜
    2006-03-24
  • 사례 출판 날짜
    2006-09-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48054
  • 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
    transdermal oxygen therapy device - Product Code KPJ
  • 원인
    Conflicting instructions are provided in the instructions for use (ifu) and the clinical users guide (cug) which accompany the epiflo device. consequently, the firm removed the cug from distribution.
  • 조치
    Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.

Device

Device Recall EpiFLO SD
  • 모델명 / 제조번호(시리얼번호)
    A total of 18 lot codes were distributed. They are as follows: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
  • 제품 설명
    Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
  • Manufacturer
    Ogenix Corporation

Manufacturer

Ogenix Corporation
  • 제조사 주소
    Ogenix Corporation, 23230 Chagrin Blvd, Suite 950, Cleveland OH 44122-5461
  • Source
    USFDA