Events

Rappel de King LTD Oropharyngeal Airways

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
    66185
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2255-2013
  • Date de mise en oeuvre de l'événement
    2013-09-03
  • Date de publication de l'événement
    2013-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121670
  • 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
    Report that size 5 kltd airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. the correct size of the kltd airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
  • Action
    King Systems notified one consignee who received the affected product verbally on August 7, 2013, via email and an Urgent Medical Device Recall - Immediate Action Required notification on September 3, 2013. The Urgent Medical Device Recall - Immediate Action Required notification described the product and issue as well as includes a response form for the consignee to complete and send back to King Systems via FAX to 317-776-5175, or email to wnet@ambu.com. Questions regarding the notice are directed to: King Systems customer service representative at 800.642.5464, Monday through Friday 8:00am- 5pm EDT. For questions regarding this recall call 317-776-6823.

Device

King LTD Oropharyngeal Airways
  • Modèle / numéro de série
    Part Number KLTD2125 Lot Number I10RG
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in NY.
  • Description du dispositif
    King LT-D Oropharyngeal Airways || The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • Adresse du fabricant
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060-4253
  • Société-mère du fabricant (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA