FDA Device recall Z-1006-2015
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package
- FDA Device
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of FLUTTER Percussor respiratory device, packaged one unit per clear plastic package by Aptalis Pharmatech, citing customer notification that the device may be difficult to open or close.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1006-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-13 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aptalis Pharmatech |
| Distribution | US |
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.
Reason
Customer notification that the device may be difficult to open or close.
Identifiers
| code_info | The affected products has lot numbers S46 and S47. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.