Events

Retiro De Equipo (Recall) de MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    47915
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-02
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Ethicon has initiated a worldwide medical device correction (notification) for unexpired lots of select ethicon mersilene tape (also referred to as mersilene polyester fiber strip or mersilene fiber ligature) products as it was discovered that a group of mersilene tape product codes are being supplied with an incorrect instructions for use (ifu) insert. the product codes subject to this correction are being supplied with a mersilene suture ifu. corrective actions are currently being implemented to include the correct mersilene tape ifu with future shipments of mersilene tape products. this notification serves as an immediate correction to provide customers with the correct mersilene tape ifu.

Device

MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE
  • Modelo / Serial
    Model Catalog: D7164 (Lot serial: All Unexpired Lots); Model Catalog: D8113 (Lot serial: All Unexpired Lots); Model Catalog: D8062 (Lot serial: All Unexpired Lots); Model Catalog: RS20 (Lot serial: All Unexpired Lots); Model Catalog: RS21 (Lot serial: All Unexpired Lots); Model Catalog: RS22 (Lot serial: All Unexpired Lots); Model Catalog: RS23 (Lot serial: All Unexpired Lots)
  • Descripción del producto
    MERSILENE NON-ABSORBABLE POLYESTER FIBER SUTURE;MERSILENE WOVEN TAPE;MERSILENE NON ABSORBABLE POLYESTER FIBER SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC