Events

Retiro De Equipo (Recall) de Device Recall Ethicon Fast Absorbing Plain Gut MultiPass Needles, Sterile, Absorbable Surgical Suture

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 Ethicon, 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
    71373
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1839-2015
  • Fecha de inicio del evento
    2015-05-08
  • Fecha de publicación del evento
    2015-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137511
  • 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
    Suture, absorbable, natural - Product Code GAL
  • Causa
    Ethicon fast absorbing surgical gut (plain) suture is being recalled because the labeling on the box and foil are incomplete.
  • Acción
    Ethicon initiated this voluntary recall by sending an Urgent: Medical Device Recall (Removal) Letter/Business Reply Form (BRF) dated May 8, 2015 to their affected customers via UPS. Stericycle will be handling returns. The letters identified the affected device and the reason for the recall. Customers were asked to examine their inventory immediately to determine if they had affected devices on hand. If so, they are to remove the affected product and communicate the issue to any necessary personnel. Customers with questions were advised to contact their local sales representative or call the Customer Support Center at 1-877-384-4266. For questions regarding this recall call 908-218-0707.

Device

Device Recall Ethicon Fast Absorbing Plain Gut MultiPass Needles, Sterile, Absorbable Surgical ...
  • Modelo / Serial
    Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US (nationwide) and Canada.
  • Descripción del producto
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. || Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA