Events

Retiro De Equipo (Recall) de Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.

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 Myco Medical Supplies Inc.

¿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
    64434
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0891-2013
  • Fecha de inicio del evento
    2013-02-07
  • Fecha de publicación del evento
    2013-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116137
  • 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
    Scalpel, one-piece - Product Code GDX
  • Causa
    Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
  • Acción
    MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.

Device

Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.
  • Modelo / Serial
    Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
  • Descripción del producto
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
  • Manufacturer
    Myco Medical Supplies Inc

Manufacturer

Myco Medical Supplies Inc
  • Dirección del fabricante
    Myco Medical Supplies Inc, 158 Towerview Ct, Cary NC 27513
  • Empresa matriz del fabricante (2017)
    Myco Medical Supplies Inc.
  • Source
    USFDA