Events

Retiro De Equipo (Recall) de Device Recall LMA(TM) MADgic(TM) LaryngoTracheal Mucosal Atomization Devices

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 Teleflex 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
    77980
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3212-2017
  • Fecha de inicio del evento
    2017-07-05
  • Fecha de publicación del evento
    2017-08-25
  • 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=158408
  • 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
    Applicator (laryngo-tracheal), topical anesthesia - Product Code CCT
  • Causa
    Teleflex medical is recalling the affected product because there may be missing or incomplete information on the package label.
  • Acción
    Teleflex sent an Urgent Medical Device Recall Notification letter on July 5, 2017, to all affected customers. The letter directed the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter." For questions regarding this recall call 866-246-6990.

Device

Device Recall LMA(TM) MADgic(TM) LaryngoTracheal Mucosal Atomization Devices
  • Modelo / Serial
    Lot Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) || MAD720 MADgic || Intended for the application of topical anesthetics to the oropharynx and upper airway region
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA