Events

Retiro De Equipo (Recall) de Situate Gauze

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 Covidien LLC.

¿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
    79296
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1130-2018
  • Fecha de inicio del evento
    2017-10-12
  • 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=161837
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Causa
    This voluntary recall is being conducted due to the potential for failure to detect the affected situate" gauze - rf and xray detectable products by the situate" detection console due to a manufacturing error.
  • Acción
    All consignees were notified via FedEx or certified mail on October 12, 2017 and the letter 'Urgent Field Corrective action Notice' informs customers of the potential for failure to detect the affected Situate" gauze RF and X-Ray detectable products by the Situate" detection console and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Correction Action Notice. For further questions, please call (203) 492-5000.

Device

Situate Gauze
  • Modelo / Serial
    Lot Number: 170704A UDI: 20884521700861
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S.
  • Descripción del producto
    Situate Gauze RF and X-Ray detectable. || Product Number: G0804-16P02CN-1 || Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA