Device Recall MEGADYNE MEDICAL PRODUCTS "12FR" SUCTION COAGULATOR

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018
  • 의료기기 분류등급
  • 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
  • 1 Event

제조사

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