Events

Rappel de Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter

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 Medical Components, Inc dba MedComp.

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
    76625
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1536-2017
  • Date de mise en oeuvre de l'événement
    2017-02-23
  • Date de publication de l'événement
    2017-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153698
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Cause
    The 9.6f port kits were packaged with the incorrect valved peelable introducer. the label states the kit contains a 10f valved peelable introducer. the kit is packaged with a 9f valved peelable introducer. the port lumen will not fit through the introducer during the insertion procedure.
  • Action
    Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.

Device

Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter
  • Modèle / numéro de série
    MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution to PR and Panama
  • Description du dispositif
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter || The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • Adresse du fabricant
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • Société-mère du fabricant (2017)
    Medical Components Inc.
  • Source
    USFDA