FDA-Device2012-09-19Class III
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
Helix Medical LLC
Hazard
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Sold states
Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
Affected count
2 devices
Manufactured in
1110 Mark Ave, N/A, Carpinteria, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2012Don't want to check this manually?
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