Retiro De Equipo (Recall) de Device Recall ReNew brand Disposable Scissor and Dissector Tips

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
    79435
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1741-2018
  • Fecha de inicio del evento
    2017-11-01
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
  • Acción
    Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to suggest that the sterile barrier provided by the sealed pouches were damaged because of the rework, but are initiating this recall out of an abundance of caution because if a sterile barrier was compromised, there is potential that use of the device could result in an infection. If you experience any adverse events or quality problems with the use of this product, you should report this to FDAs MedWatch Adverse Event Reporting Program and to Microline as soon as possible. All product returned will be replaced at no cost. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or inf o@m icr olinesur g ical.com. with any further questions. For further questions, please call (978) 867-1758.

Device

  • Modelo / Serial
    Lot Numbers: 70211  UDI: 00811099012115
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
  • Descripción del producto
    ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 || The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Microline Surgical, Inc., 50 Dunham Rd, Suite 1500, Beverly MA 01915-1882
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA