Aptalis Pharmatech Inc.: Medical Device Recall in 2015 - (Recall #: Z-1006-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 13, 2014

Date Posted: January 28, 2015

Recall Number: Z-1006-2015

Event ID: 70007

Reason for Recall:

Customer notification that the device may be difficult to open or close.

Status: Terminated

Product Quantity: Approximately 49,000 units

Code Information:

The affected products has lot numbers S46 and S47.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated