BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1006-2015 · Initiated November 13, 2014

    Recall

    Recall Number
    Z-1006-2015
    Event Number
    70007
    Firm
    Aptalis Pharmatech Inc.
    FEI Number
    1525864
    Product Code
    BYI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 13, 2014
    Posted
    January 22, 2015
    Terminated
    July 11, 2015
    Address
    845 Center Dr, Vandalia, OH, 45377-3129

    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.

    Reason

    Customer notification that the device may be difficult to open or close.

    Action

    Aptalis Pharmatech distributed a customer notification letter on November 13, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 908-927-9600.

    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.

    Quantity

    Approximately 49,000 units