Events

Retiro De Equipo (Recall) de Salter Labs Bubble humidifier

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 SALTER LABS.

¿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
    60270
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0803-2012
  • Fecha de inicio del evento
    2011-10-21
  • Fecha de publicación del evento
    2012-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104930
  • 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 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 data.
  • Notas adicionales en la data
    Humidifier, respiratory gas, (direct patient interface) - Product Code BBT
  • Causa
    A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak.
  • Acción
    Salter Labs contacted each customer directly on October 21, 2011 to inform them of the recall. Upon speaking to the direct customers, Salter Labs also provided a Recall Customer Reply Form for each direct customer to complete and return by fax to 661-854-6816 or 1-800-628-4690. Customers were instructed to immediately examine their inventory of the recalled product, remove and quarantine all affected products, indicate if product would be returned and asked if product was further distributed. If so, the second page of the response form was to be completed and returned. Customers were informed that a representatives from Salter Labs can assist, if needed, in returning all affected products to Salter and completing the attached forms. Salter's direct customers are instructed to contact their customers, should the product have undergone further distribution.

Device

Salter Labs Bubble humidifier
  • Modelo / Serial
    Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services,; MedAssurance Inc.; Abundant Home Care; Humidifier lot numbers: 091911 and 092611.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, IL, MO, NJ, OH, OK, TX and the country of: Italy
  • Descripción del producto
    Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs, AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care. || Product Usage: Humidifier - single patient use. used with supplemental oxygen therapy.
  • Manufacturer
    SALTER LABS

Manufacturer

SALTER LABS
  • Dirección del fabricante
    SALTER LABS, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA