Events

Rappel de KC 036, KC 060, KC 072 Cuffed Ventilator Tubing

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 Instrumentation Industries Inc.

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
    72396
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0269-2016
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140927
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Cause
    As a distributor of tubing manufactured by smooth bore plastics, we are initiating a product recall for specific lots of kc 036, kc 060 and kc 072 reusable ventilator tubes due to a possible manufacturing defect: a few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage.
  • Action
    Instrumentation Industries notified consignees by e-mail and telephone of the recall. The firm also sent a Notice of Product Recall letter dated September 23, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to determine if they have any of the affected product and contact the firm to make arrangements for return to Instrumentation Industries, Inc. Replacement product will be sent as soon as possible after all quality inspections have been completed. If product was further distributed consignees were asked to provide recall information to their customers. Customers with questions should call 412-854-1133, ext 433.

Device

KC 036, KC 060, KC 072 Cuffed Ventilator Tubing
  • Modèle / numéro de série
    Model Length Lot Numbers KC 036 36 tube P0614015, P0818215, P0825515  KC 060 60 tube P0511915, P0608315 KC 072 72 tube P0618415, P0818515
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including PA, FL, GA, WA, OH, CA, KA and Internationally to Canada.
  • Description du dispositif
    Ventilator Tubing
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc