Events

Retiro De Equipo (Recall) de Device Recall Bipolar Forceps

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 Stingray Surgical Products, LLC.

¿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
    62024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2011-2012
  • Fecha de inicio del evento
    2012-05-23
  • Fecha de publicación del evento
    2012-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109874
  • 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
    On 05/23/2012, stingray surgical products, llc., boca raton, fl initiated a recall initiated due to "instructions for use" of bipolar forceps not being cleared by fda and incorrect "instructions for use" . the sterilization instructions have been altered without the clearance of the fda.
  • Acción
    Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.

Device

Device Recall Bipolar Forceps
  • Modelo / Serial
    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. || Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
  • Manufacturer
    Stingray Surgical Products, LLC

Manufacturer

Stingray Surgical Products, LLC
  • Dirección del fabricante
    Stingray Surgical Products, LLC, 156 Nw 16th St, Boca Raton FL 33432-1607
  • Empresa matriz del fabricante (2017)
    Stingray Surgical Products Llc
  • Source
    USFDA