Events

Rappel de Device Recall Huber TrapA Safety Huber Needle

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 Multi-Med, 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
    56548
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2563-2010
  • Date de mise en oeuvre de l'événement
    2010-08-30
  • Date de publication de l'événement
    2010-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94032
  • 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
    Hypodermic Single Lumen Needle - Product Code FMI
  • Cause
    Huber needles may core and result in port leakage or emboli being flushed our of the port.
  • Action
    Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.

Device

Device Recall Huber TrapA Safety Huber Needle
  • Modèle / numéro de série
    Lot Code: 5l060M 6A060M 6B052M 6E028M 6H056M 6I039M 7B016M 7D008M 7E056M 7F038M 7F039M 7G052M 7K053M 8F055M 9E048M 0D003M
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Mexico.
  • Description du dispositif
    Marquette Medical Huber Trap-A Safety Huber Needle || 20ga x 1" Standard Bore Winged Administration Set || Model # MWS201 || Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
  • Manufacturer
    Multi-Med, Inc.

Manufacturer

Multi-Med, Inc.
  • Adresse du fabricant
    Multi-Med, Inc., 26 Victoria Court, Keene NH 03431
  • Société-mère du fabricant (2017)
    Multi-Med, Inc.
  • Source
    USFDA