Manufacturers

Helix Medical LLC

2 devices in the database

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
Device Recall BLOMSINGER indwelling TEP Occluder
  • Model / Serial
    Lot#1008419
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
  • Product Description
    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO || The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.