Events

Retiro De Equipo (Recall) de DISPOSASHIELD

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 O'Ryan Industries 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
    61675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1505-2012
  • Fecha de inicio del evento
    2012-04-23
  • Fecha de publicación del evento
    2012-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108697
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • Causa
    Disposa-shield disposable curing shield is recalled due to lacking 510k, pma or ide, and inadequate quality system.
  • Acción
    The firm, O'Ryan Industries Inc., began to contact consignees by telephone and sent email on April 25, 2012. O'Ryan sent a recall notification letter dated May 7, 2012 to their customers through the Purchasing Agents and Order Department Personnel. The letter described the product, problem, and actions to be taken by the customers. Customers were advised to return the Disposa-Shield back to O'Ryan Industries. Customers can call O'Ryan Industries at 800-426-4311 or fax to 360-892-6742.

Device

DISPOSASHIELD
  • Modelo / Serial
    No serial numbers, no codes, and no expiration dates.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of NC, MN, OR and WI.
  • Descripción del producto
    DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. || The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. || There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. || The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. || The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. || The product is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***info@oryanindustries.com***'. || The private label is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
  • Manufacturer
    O'Ryan Industries Inc

Manufacturer

O'Ryan Industries Inc
  • Dirección del fabricante
    O'Ryan Industries Inc, 12711 NE 95th St, Vancouver WA 98682-2412
  • Empresa matriz del fabricante (2017)
    O'Ryan Industries Inc
  • Source
    USFDA