Z-1006-2015Class II

FLUTTER Percussor respiratory device, packaged one unit per clear plastic package

Name: Z-1006-2015 FLUTTER Percussor respiratory device, packaged one unit per clear plastic package
Creator: Aptalis Pharmatech Inc.
Published: 2014-11-13
License: https://open.fda.gov/license/

Aptalis Pharmatech Inc. / initiated 2014-11-13 / Terminated / root cause: manufacturing process

FDA source

Aptalis Pharmatech Inc. began a recall of 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... on 2014-11-13. FDA classified it as Class II and gives the reason as "Customer notification that the device may be difficult to open or close". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1006-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Posted: 2015-01-22
Terminated: 2015-07-11
Recalling firm: Aptalis Pharmatech Inc.
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.
Product code: BYI Percussor, Powered-Electric
Reason for recall: Customer notification that the device may be difficult to open or close.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: The affected products has lot numbers S46 and S47.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1006-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-22

Product code BYI

K946083Class IIFlutter(r)Bradstreet Clinical Research Assoc., Inc. / cleared 1995-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)