Device Recall FLUTTER

  • Model / Serial
    The affected products has lot numbers S46 and S47.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

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