Events

Rappel de Device Recall BLOMSINGER indwelling TEP Occluder

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Helix Medical LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    62970
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2336-2012
  • Date de mise en oeuvre de l'événement
    2012-03-08
  • Date de publication de l'événement
    2012-09-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112155
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, laryngeal (taub) - Product Code EWL
  • Cause
    Helix medical llc is recalling the blom-singer indwelling tep occluder due to an invalid expiration date.
  • Action
    A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to: Helix Medical, LLC Attn to: Customer Service-IN2004-TO. 1110 Mark Avenue Carpinteria, CA 93013 For questions regarding this recall call 805-684-3304.

Device

Device Recall BLOMSINGER indwelling TEP Occluder
  • Modèle / numéro de série
    Lot#1008419
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
  • Description du dispositif
    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.
  • Manufacturer
    Helix Medical LLC

Manufacturer

Helix Medical LLC