Events

Retiro De Equipo (Recall) de Device Recall Linvatec Power Cord Reel Catalog Number:

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 Linvatec Corp. dba ConMed Linvatec.

¿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
    56829
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0847-2011
  • Fecha de inicio del evento
    2010-02-23
  • Fecha de publicación del evento
    2011-01-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94603
  • 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
    Camera, surgical and accessories - Product Code KQM
  • Causa
    Conmed linvatec, endoscopy division, dba. conmed linvatec, largo, florida is recalling five products: (1.) video cart premium 120 vac (vp6501), (2.) video cart multi-specialty 120 vac (vp6502), (3.) video cart articulating arm 120v (vp6504), (4.) video cart (vp8500), and (5.) power cord assembly self retracting (vp6547). these products are being recalled due to there is a possibility that the vid.
  • Acción
    ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062. For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail Custserv1@Invatec.com.

Device

Device Recall Linvatec Power Cord Reel Catalog Number:
  • Modelo / Serial
    Power Cord Assembly Self Retracting (Catalog Number: VP6547)  Lot Number: 1160 1533 1590 1959 2534 2558 2595 2724 2798 2905 3009 3269 3428 3831 3831 4099 4498 4894 5209
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.
  • Descripción del producto
    The Power Cord Reel is labeled as follows: || REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. || These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties || MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Dirección del fabricante
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA