Z-1006-2015 Class II Terminated
FDA device recall Z-1006-2015 was initiated by Aptalis Pharmatech Inc. on November 13, 2014 and is designated Class II. Reason for recall: Customer notification that the device may be difficult to open or close. The recall status is terminated (terminated July 11, 2015). Affected quantity: Approximately 49,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2015
- Initiation Date
- November 13, 2014
- Termination Date
- July 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 49,000 units
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.
Reason for Recall
Customer notification that the device may be difficult to open or close.
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.
Code Information
The affected products has lot numbers S46 and S47.