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

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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