Retiro De Equipo (Recall) de Remove and Skin Prep Wipes

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Smith Nephew Lab.

¿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
  • Fecha
    2011-04-21
  • País del evento
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    Smith & Nephew made the decision to voluntarily recall the batches listed below of REMOVE and SKIN-PREP wipes made for Smith & Nephew by TRIAD. This recall decision was made following a recommendation from the FDA. It was determined that these specific batches of products were manufactured in the same manufacturing plant as other alcohol-based wipes manufactured by TRIAD and that are subject to further voluntary recall due to a potential risk bacterial contamination. The relevant European Competent Authorities are informed of this measure by the manufacturer. List of lots concerned. Wording of the product AC Code. Smith & Nephew Reference. Presentatio. Command unit. Lot. REMOV. . 700519.. 5940312.. Wipes impregnated with solvan. . 1 box of 50 sachet. . 0E219, 0E226, 0F242, 0G116, 0H256, 0J233, 0J262, 0J263, 0M178, 0M179, 1A106, 1A181, 1A182, 1A19. . SKIN-PRE. . 700515.. 5942042.. Wipes impregnated. . 1 box of 50 sachet. . 0G117, 0G225, 0J146, 0J147, 0K78, 0M198

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM