Events

Retiro De Equipo (Recall) de Device Recall S.A.L.T. Airway Device

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
    Recall
  • ID del evento
    57743
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1885-2011
  • Fecha de inicio del evento
    2011-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97299
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Causa
    Product contains triad lubricating jelly which was recalled.
  • Acción
    The firm, Microtek Medical, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and place any S.A.L.T. Airway Device (79-580) in quarantine; if they have distributed any of the product, they should identify their customers and notify them at once of this recall; complete and return the enclosed URGENT: MEDICAL DEVICE RECALL-RETURN RESPONSE form via fax to: (662)244-3011 or email: tom.bonner@ecolab.com, and return any unused product inventory to Microtek Medical. The firm will provide the customers with a replacement product as soon as product becomes available. If you have any questions in regards to this recall, please feel free to contact the V.P.-Regulator Affairs at 1-888-844-0988 or email: Tom.bonner@ecolab.com.

Device

Device Recall S.A.L.T. Airway Device
  • Modelo / Serial
    Lot Numbers: C10259 and D103334
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
  • Descripción del producto
    MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials || Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.
  • Manufacturer
    Microtek Medical Inc

Manufacturer

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