Device Recall IMA/ENT Blade Electrode

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 809335, Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries of Canada, Australia and Singapore.
  • 제품 설명
    WECK IMA/ENT Blade Electrode ¿ (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC || The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA