Events

Rappel de Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra

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 B. Braun Medical, 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
    49565
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0199-2009
  • Date de mise en oeuvre de l'événement
    2008-09-17
  • Date de publication de l'événement
    2008-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73817
  • 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
    Intravascular Administration Set - Product Code FPA
  • Cause
    Product was assembled incorrectly and connected to the wrong part.
  • Action
    The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.

Device

Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra
  • Modèle / numéro de série
    Item number 474515. Lot number 0061014615 exp 6/30/2013
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
  • Description du dispositif
    Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA