Events

Device Recall Genicon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Genico, Inc., dba Genicon 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
    50739
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1956-2009
  • 사례 시작날짜
    2008-05-08
  • 사례 출판 날짜
    2009-07-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76839
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • 원인
    Genicon is recalling the genicon disposable suction irrigation 5mm 700-005-010 and 10mm 700-005-005 tube sets. the caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the suction irrigation device.
  • 조치
    All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).

Device

Device Recall Genicon
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 441071225, 434071227, 434080237 and 434080373.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
  • 제품 설명
    Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. || A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.
  • Manufacturer
    Genico, Inc., dba Genicon

Manufacturer

Genico, Inc., dba Genicon
  • 제조사 주소
    Genico, Inc., dba Genicon, 6869 Stapoint Ct Ste 114, Winter Park FL 32792-6603
  • 제조사 모회사 (2017)
    Genicon Inc
  • Source
    USFDA