Events

Rappel de Device Recall Spectra Optia Apheresis System

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 Caridian BCT, Incorporated.

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
    58909
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2674-2011
  • Date de mise en oeuvre de l'événement
    2010-12-09
  • Date de publication de l'événement
    2011-06-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100504
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Cause
    An additional air detection system is being added to all existing systems to detect air in the system's return line.
  • Action
    CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.

Device

Device Recall Spectra Optia Apheresis System
  • Modèle / numéro de série
    Serial Numbers: 1P00100 thru 1P00719
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • Description du dispositif
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
    Caridian BCT, Incorporated

Manufacturer

Caridian BCT, Incorporated
  • Adresse du fabricant
    Caridian BCT, Incorporated, 10811 W Collins Ave, Lakewood CO 80215-4440
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA