Events

Retiro De Equipo (Recall) de COATED VICRYL RAPIDE 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
    22212
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-09-08
  • 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
    Manufacturer has identified that certain lots of sizes 2-0 and 4-0 for vicryl rapidet suture exhibited suture damage due to a manufacturing equipment issue. the manufacturing equipment issue has been corrected. the medical assessment concluded that this situation could result in a potential superficial wound dehiscence or contribute to impaired wound healing but only occasionally and/or under unusual circumstances. manufacturer has not received any reports of adverse events associated with the product subject to this recall.

Device

COATED VICRYL RAPIDE SUTURE
  • Modelo / Serial
    Model Catalog: VR496 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7686); Model Catalog: VR2297 (Lot serial: AH7711); Model Catalog: VR496 (Lot serial: AH7711); Model Catalog: VR945 (Lot serial: AH7711); Model Catalog: VR2297 (Lot serial: AJ0770); Model Catalog: VR496 (Lot serial: AJ0770); Model Catalog: VR945 (Lot serial: AJ0770); Model Catalog: VR2297 (Lot serial: AJ0794); Model Catalog: VR496 (Lot serial: AJ0794); Model Catalog: VR945 (Lot serial: AJ0794); Model Catalog: VR2297 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7680); Model Catalog: VR496 (Lot serial: AH7680); Model Catalog: VR2297 (Lot serial: AH7680); Model Catalog: VR945 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH6611); Model Catalog: VR945 (Lot serial: AH6611); Model Catalog: VR2297 (Lot serial: AH7694); Model Catalog: VR2297 (Lot serial: AH6611)
  • Descripción del producto
    COATED VICRYL RAPIDE 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