FDAClass IIJanuary 28, 2015

FLUTTER Percussor respiratory device recall

FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used…

Why was FLUTTER Percussor respiratory device recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

The affected products has lot numbers S46 and S47.

Product
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used…
Recalling firm
Aptalis Pharmatech Inc.
Quantity
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.
Recall date
January 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls