Recall Z-1006-2015
Aptalis Pharmatech Inc. · initiated November 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: The affected products has lot numbers S46 and S47.
Reason for recall
Customer notification that the device may be difficult to open or close.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1006-2015
- Initiated
- November 13, 2014
- Posted by FDA
- January 22, 2015
- Terminated
- July 11, 2015
- Product code
- BYI – Percussor, Powered-Electric
- Quantity
- Approximately 49,000 units
- 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.
- Recalling firm
- Aptalis Pharmatech Inc., Vandalia, OH