FDAFDA · Alimentos y medicamentos·N.º oficial Z-2336-2012
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.
Publicado el 19 de septiembre de 2012 · Inicio del retiro: 8 de marzo de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Helix Medical LLC
- Distribuidor
- Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
- Lote
- Lot#1008419
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States