Events

Rappel de Device Recall 9F Plastic Dual 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 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
    70457
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1527-2015
  • Date de mise en oeuvre de l'événement
    2015-01-28
  • Date de publication de l'événement
    2015-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133828
  • 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 and catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Cause
    The dual port with catheters was not covered under fda clearance.
  • Action
    Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.

Device

Device Recall 9F Plastic Dual Port
  • Modèle / numéro de série
    Model No. MR592090A, MR592090P; with Lot Nos.:  MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
  • Description du dispositif
    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
  • 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
  • Société-mère du fabricant (2017)
    Medical Components Inc.
  • Source
    USFDA