Events

Rappel de Device Recall Face Tent with 15 mm Adapter

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
    57972
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1888-2011
  • Date de mise en oeuvre de l'événement
    2011-01-24
  • Date de publication de l'événement
    2011-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97884
  • 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
    Oxygen Mask - Product Code BYG
  • Cause
    The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. the sticky substance could result in inconvenience or in some remote cases cause patient harm.
  • Action
    The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.

Device

Device Recall Face Tent with 15 mm Adapter
  • Modèle / numéro de série
    IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.
  • Description du dispositif
    Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. || An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
  • 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