Events

Device Recall POOLE Suction Instrument 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Conmed 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
    37346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0593-2007
  • 사례 시작날짜
    2006-11-10
  • 사례 출판 날짜
    2007-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50403
  • 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
    Surgical Suction Instrument - Product Code GCJ
  • 원인
    Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
  • 조치
    On 11/10/06, ConMed Corp. sent "URGENT: DEVICE RECALL" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.

Device

Device Recall POOLE Suction Instrument
  • 모델명 / 제조번호(시리얼번호)
    REF 0035040; All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • 제조사 주소
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA