Recall Z-1006-2015 ยท BYI Percussor, Powered-Electric
Aptalis Pharmatech Inc.
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.
| Date | Jan 22, 2015 (initiated Nov 13, 2014) |
| Status | Terminated |
| Reason | Customer notification that the device may be difficult to open or close. |
| Root cause | Process control |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946083 | FLUTTER(R) Bradstreet Clinical Research Assoc., Inc., Mar 13, 1995 |