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Devices
Device Recall BlomSinger Adjustable Tracheostoma Valve II
Model / Serial
LOTS: 1057760, 1057919 and 1059222
Product Classification
Ear, Nose, and Throat Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Product Description
Blom-Singer Adjustable Tracheostoma Valve II || Models: BE8025H and BE8025H-R3
Manufacturer
Helix Medical LLC
1 Event
Recall of Device Recall BlomSinger Adjustable Tracheostoma Valve II
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Manufacturer
Helix Medical LLC
Manufacturer Address
Helix Medical LLC, 1110 Mark Ave, Carpinteria CA 93013-2918
Manufacturer Parent Company (2017)
Freudenberg & Co. Kommanditgesellschaft
Source
USFDA
Language
English
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