Events

Retiro De Equipo (Recall) de Device Recall Custom Procedural Trays

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 Merit Medical Systems, 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
    64078
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1660-2013
  • Fecha de inicio del evento
    2012-11-21
  • Fecha de publicación del evento
    2013-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115330
  • 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 (kit) - Product Code LRO
  • Causa
    Custom procedural trays contain medrad hand controller sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
  • Acción
    Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" letter dated November 21, 2012, to affected customer. The letter identified the product, the problem, and the action to be taken by the customer: Ensure all personnel within their institution to which the affected Merit trays were distributed are notified, quarantine all affected trays and return the affected product to Merit - Maastricht. Complete and sign the Customer Response Form attached to this letter and perform the following steps:(1) Immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031. (2) Mail the completed original Customer Response Form from (1) above using the provided postage-paid, self-addressed envelope to Merit. Product Return Instructions: Please return the affected products by shipping them back to Merit via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department, RGA #NC-54948 Merit Medical Maastricht, Amerikalaan 42, 6199 AE Maastricht - Airport, The Netherlands. NOTE: A copy of the Customer Response Form must accompany the shipment. If you have any questions, please call 1-804-416-1048.

Device

Device Recall Custom Procedural Trays
  • Modelo / Serial
    Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S. Military Hospital on base in Landstuhl, Germany
  • Descripción del producto
    Custom Procedural Trays: Merit's Custom Angio Kits || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc
  • Source
    USFDA