Device Recall FLUTTER

  • 모델명 / 제조번호(시리얼번호)
    The affected products has lot numbers S46 and S47.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of OH, NM, CO, NC, IL, MD, LA, MN, NJ, SC, AL, VA, MI, MA, and CA. in the countries of: Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.
  • 제품 설명
    FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. || Product Usage: || Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Aptalis Pharmatech Inc., 845 Center Dr, Vandalia OH 45377-3129
  • Source
    USFDA