Events

Retiro De Equipo (Recall) de PVP Prep Solution

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 Custom Medical Specialties, Inc..

¿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
    62875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2331-2012
  • Fecha de publicación del evento
    2012-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111924
  • 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
    Tray, surgical - Product Code LRP
  • Causa
    The firm saw on the fda web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
  • Acción
    Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (919) 202-8462, ext 205 to obtain a Return Authorization Number and the shipping number. For questions regarding this recall call 919-202-8462.

Device

PVP Prep Solution
  • Modelo / Serial
    14327-0902, 19929-1006
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including GA, MI, NY, and PA.
  • Descripción del producto
    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution || CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
  • Manufacturer
    Custom Medical Specialties, Inc.

Manufacturer

Custom Medical Specialties, Inc.
  • Dirección del fabricante
    Custom Medical Specialties, Inc., 330 East Main Street, Pine Level NC 27568
  • Source
    USFDA