Events

Retiro De Equipo (Recall) de Device Recall Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"

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
    61908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1694-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109367
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • Acción
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com

Device

Device Recall Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"
  • Modelo / Serial
    Lot Codes:  013816, 017007, 019113, 020608, 029905
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
  • Descripción del producto
    Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" || Product ID: 8881511144 || Indications for Use: Injection of U-1 00 insulin
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • 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