FDA-Device2013-11-13Class III
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Helix Medical LLC
Hazard
InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Affected count
47 units
Manufactured in
1110 Mark Ave, N/A, Carpinteria, CA, United States
Products
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0128-2014Don't want to check this manually?
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