Events

Retiro De Equipo (Recall) de Device Recall AVID TruCustom

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 Avid Medical, 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
    79162
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0783-2018
  • Fecha de inicio del evento
    2017-06-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161478
  • 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
    General surgery tray - Product Code LRO
  • Causa
    Certain kits packed by the firm contain bd 22ga 1-1/2 inch safetyglide non sterile bulk needles that may contain loose polypropylene foreign material above the release specification.
  • Acción
    An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to QualityAssurance@owens-minor.com that your customers were notified.

Device

Device Recall AVID TruCustom
  • Modelo / Serial
    Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
  • Descripción del producto
    AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

Avid Medical, Inc.
  • Dirección del fabricante
    Avid Medical, Inc., 9000 Westmont Dr, Toano VA 23168-9351
  • Source
    USFDA