Events

Retiro De Equipo (Recall) de Respire Pink Hard

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 Respire Medical.

¿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
    80030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1949-2018
  • Fecha de inicio del evento
    2017-09-01
  • Fecha de publicación del evento
    2018-05-29
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164537
  • 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
    Dental Device, anti-snoring - Product Code LRK
  • Causa
    Potential for device breakage during use.
  • Acción
    On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions: - Immediately examine your inventory, discontinue use and quarantine product subject to recall. - In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice. - Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge. Customers with questions may call (718) 643-7326, Monday  Friday 7am to 7pm.

Device

Respire Pink Hard
  • Modelo / Serial
    Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US nationwide distribution.
  • Descripción del producto
    Respire Pink+ Hard Oral Sleep Apnea Device
  • Manufacturer
    Respire Medical

Manufacturer

Respire Medical
  • Dirección del fabricante
    Respire Medical, 18 Bridge St Ste 4J, Brooklyn NY 11201-1107
  • Empresa matriz del fabricante (2017)
    Respire Medical Holdings Llc
  • Source
    USFDA