Events

Retiro De Equipo (Recall) de Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip

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 Microline Surgical, 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
    59469
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3086-2011
  • Fecha de inicio del evento
    2011-07-18
  • Fecha de publicación del evento
    2011-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102847
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Mislabeled: renew product number 3262 (long fenestrated grasper) was packaged and labeled as product number 3642 (super-atrau fenestrated grasper). renew product number 3642 (super-atraumatic fenestrated grasper) was packaged and labeled as 3262 (long fenestrated grasper.
  • Acción
    Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.

Device

Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper For...
  • Modelo / Serial
    Lot Number: 00105709 Expiration date: 5-2016
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  • Descripción del producto
    Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip || Ref: 3642 || The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula
  • Manufacturer
    Microline Surgical, Inc.

Manufacturer

Microline Surgical, Inc.
  • Dirección del fabricante
    Microline Surgical, Inc., 800 Cummings Ctr Ste 166t, Beverly MA 01915-6171
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA