Events

Rappel de Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port

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 Teleflex Medical.

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
    67266
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0950-2014
  • Date de mise en oeuvre de l'événement
    2014-01-06
  • Date de publication de l'événement
    2014-02-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125113
  • 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, tracheal (w/wo connector) - Product Code BTR
  • Cause
    The tracheal tube can kink during patient use.
  • Action
    Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881. Consignees with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 919-572-8014.

Device

Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port
  • Modèle / numéro de série
    Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
  • Description du dispositif
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, || Product Usage: || A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA