Events

Rappel de VCATH Insertion Kits

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 Neo 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
    58514
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2223-2011
  • Date de mise en oeuvre de l'événement
    2011-04-05
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99502
  • 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
    I.V. Start Kit - Product Code LRS
  • Cause
    Firm received recall notice from their contract manufacturer due to visible particulates in bacteriostatic sodium chloride injection, usp 0.9%, 30 ml vials that are included in insertion kits.
  • Action
    Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or pjduvall@neomedicalinc.com. Replacement or credit would be issued for all product returned.

Device

VCATH Insertion Kits
  • Modèle / numéro de série
    Lot # Expiration Date 2009092850 5/31/2011 2010012950 5/31/2011 2010030150 8/31/2011 2010043050 8/31 2011 2010061850 12/31/2011 2010062950 12/31/2011 2010082650 12/31/2011
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.
  • Description du dispositif
    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; || Manufactured by Centurion Medical Products for Neo Medical; || 42514 Albrae Street, Fremont, CA 94538
  • Manufacturer
    Neo Medical, Inc.

Manufacturer

Neo Medical, Inc.
  • Adresse du fabricant
    Neo Medical, Inc., 42514 Albrae St., Fremont CA 94538
  • Société-mère du fabricant (2017)
    Neo Medical Inc
  • Source
    USFDA