Events

Retiro De Equipo (Recall) de Device Recall North Coast MediTek Inc Biopsy Trays

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 North Coast Medi-Tek 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
    59386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2982-2011
  • Fecha de inicio del evento
    2011-05-13
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102584
  • 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
    General surgery tray - Product Code LOR
  • Causa
    During routine bioburden testing, unusually high results were found for a bioburden test done on 4/19/11. bioburden level reported as >150,000 cfu. our alert level is 17,000 cfu and the action level is 23,000 cfu.
  • Acción
    North Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product. For further questions please call (440) 974-0750.

Device

Device Recall North Coast MediTek Inc Biopsy Trays
  • Modelo / Serial
    Model #'s: 255566, 260945, XP-2033, 266970, XP-1800R1, 254112 & NC-4072, Lot #1114 Exp. 10/13
  • Distribución
    Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX
  • Descripción del producto
    Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. || Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
  • Manufacturer
    North Coast Medi-Tek Inc

Manufacturer

North Coast Medi-Tek Inc
  • Dirección del fabricante
    North Coast Medi-Tek Inc, 8603 East Ave, Mentor OH 44060-4366
  • Source
    USFDA