Events

Device Recall Hyfrecator 2000 Electrosurgical Units 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
    76482
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1756-2017
  • 사례 시작날짜
    2017-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153471
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    For over a year, the accessory packages in the hyfrecator 2000 esu cartons were packaged in error by the manufacturer with non-sterile p/n 7-796-19 handpiece sheaths in pouches that were labeled as sterile. this could cause an end user to use a non-sterile sheath as if it were sterile.
  • 조치
    ConMed sent an URGENT: MEDICAL DEVICE RECALL Notices (dated 2/28/2017)to all affected US customers by USPS First Class Mail. International letters are in the process of translation and are scheduled to be sent by March 15, 2017. Customers were instructed to review their inventory for any of the affected product and were asked to complete the business reply form and return it to ConMed Corporation, 525 French Road, Utica, New York 13502. Customers with questions or requests should contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email hyfr2000@conmed.com. For questions regarding this recall call 315-624-3533.

Device

Device Recall Hyfrecator 2000 Electrosurgical Units
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010,  15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
  • 제품 설명
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA