Events

Retiro De Equipo (Recall) de Device Recall Acacia IV Extension Set with BD QSyte

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 Medical Product Specialist Inc dba MPS Acacia.

¿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
    54181
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1080-2010
  • Fecha de inicio del evento
    2009-12-18
  • Fecha de publicación del evento
    2010-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87776
  • 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
    IV Extension Set - Product Code FPA
  • Causa
    Some lots of iv extension sets with bd q-syte luer access split septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
  • Acción
    A letter dated December 18, 2009 was sent to Acacia customers with the following instructions. 1. Immediately review your inventory of Acacia IV Extension Sets with BD Q-Syte for REF numbers and lot numbers listed and remove them from all inventory printed on the unit packaging , shelf box and shelf shipper containers. 2. Complete the Distributor Recall response Card (Attachment 1) and return by fax immediately to the number on the Distributor Recall Response Card for product in your facility at the time of receipt of this letter. This form must be completed and f axed to Acacia, Inc even if there is no product in inventory. 3. Acacia, Inc is currently working to ensure that replacement products are readily available. Once you have identified how much product you will be returning, please call your Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, to arrange for product replacement. Questions are to be directed to the Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, between 8:00AM and 5:00PM MST, Monday-Friday.

Device

Device Recall Acacia IV Extension Set with BD QSyte

Manufacturer

Medical Product Specialist Inc dba MPS Acacia
  • Dirección del fabricante
    Medical Product Specialist Inc dba MPS Acacia, 785 Challenger St, Brea CA 92821-2948
  • Source
    USFDA