Retiro De Equipo (Recall) de Device Recall VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE

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 Microtek Medical 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Apparatus, exhaust, surgical - Product Code FYD
  • Causa
    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 cfr 801.437; it does not contain caution: the packaging of this product contains natural rubber latex which may cause allergic reactions.
  • Acción
    The firm, Ecolab - Microtek Medical, sent an "Urgent: Recall - Mislabeled Product Immediate Action Required" letter dated March 2015 to its US customers on 03/10/2015 via letter and email. The letter describes product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and promptly quarantine the lot(s) listed; complete and return the enclosed Recall Response Form via fax to Quality Assurance Manager, Ecolab-Microtek Medical at (662) 244-3011 or email to: RE: Recall - Mislabeled Product ASAP, and if you have further distributed the products subject to this recall, please notify your customers at once. Upon receipt of the completed response forms, Ecolab-Microtek Medical will issue a return material authorization (RMA) and ask that you return any unopened product listed above to Ecolab-Microtek Medical at the address listed in the attached form. If you have any questions in regard to this recall, please contact Customer Service by phone at 1-800-824-3027 or email;


  • Modelo / Serial
    Lot Numbers: C10147, C10166, C10169, C10174, C10196, C10201, C10207, C10210, C10236, C10298, C11067, C11089, C11108, C11194, C11208, C11238, C11271, C11311, C11362, C12009, C12020, C12032, C12034,C12058, C12081, C12118, C12165, C12187, C12214, C12228, C12303, C12333, C13014, C13050, C13072, C13214, C13282, C13291, C13322, C14090, C14209
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US (nationwide) Distribution.
  • Descripción del producto
    VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO || Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
  • Manufacturer


  • Dirección del fabricante
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • Empresa matriz del fabricante (2017)
  • Source