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Helix Medical LLC recalls Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Recalled November 13, 2013 · FDA recall Z-0128-2014 · Helix Medical
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. · FDA Class III
Units
47 units
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Description
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.
Product
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Manufacturer(s)
Helix Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →