Events

Rappel de Device Recall KING LTS D, Size 3, 100025 Oropharyngeal Airway

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 King Systems Corp..

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
    54350
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0977-2011
  • Date de mise en oeuvre de l'événement
    2009-12-15
  • Date de publication de l'événement
    2011-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88831
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Cause
    King systems was issued a warning letter from the center for devices and radiological health, office of compliance on october 28, 2009. the warning letter asserts that kings systems klt(s)-d airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat.
  • Action
    On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: LTSD@kingsystem.com.

Device

Device Recall KING LTS D, Size 3, 100025 Oropharyngeal Airway
  • Modèle / numéro de série
    all product produced prior to 12/2009.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.
  • Description du dispositif
    KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060. || Intended use: Airway management by providing a patent airway to allow patient ventilation.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Adresse du fabricant
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • Société-mère du fabricant (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA