FDANovember 13, 2014device
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 fibrou...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Customer notification that the device may be difficult to open or close.
What to do
FDA enforcement status: Terminated
Brands named
aptalis pharmatechaptalis
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDARugby Tri-Vitamin Liquid 1 2/3 fl. oz. (50 mL) UPC 00536-8501-802017-08-16
- FDAMajor Certa-Vite Liquid 236 mL UPC 00904-5023-092017-08-16
- FDARugby FER Iron Liquid 50 mL UPC 00536-0710-802017-08-16
- FDAMajor D-Vita Drops 50 mL UPC 00904-6273-502017-08-16
- FDAMajor Poly-Vita Drops w/ Iron 50 mL UPC 00904-5100-502017-08-16
- FDARugby D3 Vitamin liquid 400 IU/1 mL dose 1 2/3 fl. oz. (50 mL) UPC 00536-8400-802017-08-16
- FDARugby Ferrous Sulfate Elixir 473 mL UPC: 00536-0650-852017-08-16
- FDARugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL2017-08-16
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