Events

Retiro De Equipo (Recall) de Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

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 LP.

¿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
    57315
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0567-2011
  • Fecha de inicio del evento
    2010-11-15
  • Fecha de publicación del evento
    2010-12-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95828
  • 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
    Saline, vascular access flush - Product Code NGT
  • Causa
    The heparin sodium usp used to manufacture was produced with crude heparin containing over-sulfated chondroitin sulfate.
  • Acción
    COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to adfeedback@coviden.com following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888

Device

Device Recall MONOJECT Prefill Heparin Lock Flush Syringe
  • Modelo / Serial
    Lot # 9082094
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Descripción del producto
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881590123
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Dirección del fabricante
    Covidien LP, 15 Hampshire St, 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