Events

Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Megadyne Medical Products, 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
    67641
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1151-2014
  • 사례 시작날짜
    2014-02-27
  • 사례 출판 날짜
    2014-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-07-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125887
  • 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
    Megadyne medical products, inc. is voluntarily recalling hand control 12fr suction coagulator with 10ft cord and 132405 holster, sterile, disposable, lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
  • 조치
    Megadyne Medical Product sent an Urgent Medical Device Recall letter dated February 27, 2014, to all affected customers with follow-up phone calls and emails. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed toexamine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to remove the product from service and contact Megadyne Customer Service at 1-801-576-9669 or 1-800-747-6110 for return authorization and replacement or credit. If customers have distributed any the affected product, they were instructed to immediately contact their distribution points to have the product returned to Megadyne. Customers with questions were instructed to contact Customer Service at 1-800-747-6110 or 1-801-576-9669 or email Regulatory @Megadyne.com. For questions regarding this recall call 801-576-9669.

Device

Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
  • 제품 설명
    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. || This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
  • Manufacturer
    Megadyne Medical Products, Inc.

Manufacturer

Megadyne Medical Products, Inc.
  • 제조사 주소
    Megadyne Medical Products, Inc., 11506 South State Street, Draper UT 84020-9453
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA