Events

Retiro De Equipo (Recall) de Device Recall CENTURION PICC INSERTION TRAY

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Centurion Medical Products Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58346
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2296-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99039
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Kit, i.V. Start - Product Code LRS
  • Causa
    This voluntary recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
  • Acción
    Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

Device

Device Recall CENTURION PICC INSERTION TRAY
  • Modelo / Serial
    BATCH 2010050750
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Material, CVI2615, PICC INSERTION TRAY || PICC Insertion Tray, Reorder || CVI2615, CENTURION MEDICAL PRODUCTS CORP, WILLIAMSTON MI 48895, USA I 800.248.4058 www.centurionmp.com, CENTURION¿ || FACILITATES PICC LINE PLACEMENT
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Dirección del fabricante
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA