Events

Retiro De Equipo (Recall) de Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

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 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables.

¿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
    78950
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0541-2018
  • Fecha de inicio del evento
    2017-06-27
  • 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=160950
  • 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
    Lumbar puncture tray (adult & pediatric) - Product Code PWY
  • Causa
    Bd safetyglide needle 22ga 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
  • Acción
    On June 27, 2017, Busse Hospital Disposables distributed Urgent Medical Device Recall notices and Response Forms to their customers via courier service. A copy of the supplier's recall notice was also provided to customers. Customers were advised to conduct the following: " Discontinue use of needle immediately. " Please check your inventory and cease distribution immediately. " If you have distributed the above products, please contact your customers and inform them of this recall immediately. " Contact Busse Hospital Disposables for a Return Good Authorization number. " Complete and Return the Response Form via fax to 631-435-2849 or via email to: ijacobo@busseinc.com. Customers with questions may call 631-435-4711, ext. 254.

Device

Device Recall SafetyDeluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle

Manufacturer

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
  • Dirección del fabricante
    Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, 75 Arkay Dr, Hauppauge NY 11788-3707
  • Empresa matriz del fabricante (2017)
    Robert Busse & Co. Inc.
  • Source
    USFDA