Reported Jan 28, 2015 · Terminated

FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a…

Aptalis Pharmatech Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aptalis Pharmatech Inc. · 845 Center Dr · Vandalia, OH · 45377-3129

Is this the product you have?

  • FLUTTER Percussor respiratory device, packaged one unit per clear plastic package
  • Product UsageProduct is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing
  • respiratory conditions such asatelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma
Lot codes and dates
  • The affected products has lot numbers S46 and S47.
Amount recalled
Approximately 49,000 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2015 · Data as of Sep 19, 5:27 PM UTC

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