Device product
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.
Z-1006-2015
Product summary
- Event
- Event 70007
- Status
- Terminated
- Classification
- Class II
- Quantity
- Approximately 49,000 units
- Official record key
device-enforcement:Z-1006-2015
Official wording
Reason: Customer notification that the device may be difficult to open or close.
Code information: The affected products has lot numbers S46 and S47.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Customer notification that the device may be difficult to open or close.