LMA

  • 모델명 / 제조번호(시리얼번호)
    Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
  • 제품 설명
    LMA MADomizer, Rx only, || Product Usage: || These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
  • Source
    USFDA