Device recall
Z-1006-2015: FLUTTER Percussor respiratory device, packaged one unit per clear plastic…
FDA device recall · Class II · Aptalis Pharmatech Inc.
Key facts
| Recall number (Z-number) | Z-1006-2015 |
|---|---|
| Recall event | 70007 |
| 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… |
| Product code | BYI |
| Recalling firm | Aptalis Pharmatech Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2015 |
| 510(k) numbers | K946083 |
| FEI number | 1525864 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database