Events

Rappel de Device Recall Universal Flex2 Breathing Circuit

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
    66184
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2272-2013
  • Date de mise en oeuvre de l'événement
    2012-08-23
  • Date de publication de l'événement
    2013-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121659
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Cause
    King systems received a customer complaint indicating that the customer had ordered a breathing circuit with a latex breathing bag. the product they received contained a latex breathing bag, but was labeled as non-latex.
  • Action
    Ambu, Inc. sent a letter dated June 24, 2013, informing the customer that they have decided to discontinue the manufacture and sales of the King Systems latex breathing bags and to conver all customers to their King Systems latex-free breathing bags. The customer was advised to adjust their inventories accordingly and transition to the latex free part number as their inventory levels reach their minimums. For questions the customer was advised to call 317-403-8677. For questions regarding this recall call 317-776-6823.

Device

Device Recall Universal Flex2 Breathing Circuit
  • Modèle / numéro de série
    Part Number DF4110-61 Lot Number I063N
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - NE only.
  • Description du dispositif
    Universal Flex2 Breathing Circuit || Class I || 510(k) Exempt || An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
  • 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