Events

Recall of Device Recall FLUTTER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aptalis Pharmatech Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70007
  • Event Risk Class
    Class 2
  • Event Number
    Z-1006-2015
  • Event Initiated Date
    2014-11-13
  • Event Date Posted
    2015-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132103
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Percussor, powered-electric - Product Code BYI
  • 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.

Device

Device Recall FLUTTER
  • Model / Serial
    The affected products has lot numbers S46 and S47.
  • Product Classification
    Anesthesiology Devices
  • 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
    Aptalis Pharmatech Inc.

Manufacturer

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