Events

Rappel de Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector

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 Halyard Health, 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
    79479
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1277-2018
  • Date de mise en oeuvre de l'événement
    2017-12-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162433
  • 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
    Filter, infusion line - Product Code FPB
  • Cause
    The transmitting stylet within cortrak* 2 nasogastric/nasointestinal (ng/ni) feeding tubes with anti-iv* connector (product code 20-9551trak2a) may be visible within the window of the exit port of the feeding tube. based on specifications, the transmitting stylet in the ng tube should not be visible within the port window.
  • Action
    The firm, Halyard, sent an "URGENT: Product Advisory Notice" letter dated 12/13/2017 to its customers on about 12/13/2017. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Instructions for distributors included to examine unsold inventory for impacted lots, complete and return the Distributor Product Advisory Notice Acknowledgement Form, and send the attached End-User/Customer Product Advisory Notice and Acknowledgement Form to all end user customers who would have potentially received impacted product by email to: monica.king@hyh.com or by FAX to: 678-254-0347. A Halyard Customer Service Representative will contact the distributors if affected product was on hand. Instructions for End-User/Customers included to evaluate the clinical facility's unused inventory for impacted lots, inform all clinicians in the facility who may use potentially impacted devices to verify that the stylet tip is not visible within the window of the exit port after engaging the stylet with the port connector of the NG/NI Feeding Tube, and if it is visible, do not use the device. Additionally they were asked to complete and return the Product Advisory Notice Acknowledgement Form by email to: monica.king@hyh.com or by FAX to: 678-254-0347. If you require further assistance, please call Halyard Regulatory Affairs at 678-477-4165. You may also contact Halyard Customer Service at 1-844-HALYARD (1-844-425-9273, OPTION 1, OPTION 3).

Device

Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector
  • Modèle / numéro de série
    Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
  • Description du dispositif
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm || The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • Adresse du fabricant
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA