Recall Z-1006-2015— Aptalis Pharmatech Inc.

Name: FDA recall Z-1006-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-13

Class II · Terminated

Class II FDA medical device recall by Aptalis Pharmatech Inc., initiated 2014-11-13, terminated 2015-07-11. It names one FDA 510(k) clearance: K946083. 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.. Reason: Customer notification that the device may be difficult to open or close..

Recalling firm: Aptalis Pharmatech Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Terminated: 2015-07-11
Firm location: Vandalia, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K946083 — FLUTTER(R)Bradstreet Clinical Research Assoc., Inc.·cleared 1995-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.