Events

Retiro De Equipo (Recall) de Device Recall Wound Closure Device

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 Zipline Medical.

¿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
    70466
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1235-2015
  • Fecha de inicio del evento
    2015-02-05
  • Fecha de publicación del evento
    2015-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133840
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Causa
    The manufacturers seal may not be present on the nylon pouch resulting in lack of assurance for sterility.
  • Acción
    Zipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.

Device

Device Recall Wound Closure Device
  • Modelo / Serial
    Lot 1002750, Exp 2016-09
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
  • Descripción del producto
    Zip 8M Wound Closure Device; || for wounds up to 8 cm in length; || Product number PS9080; || Rx only, Sterile || Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
  • Manufacturer
    Zipline Medical

Manufacturer

Zipline Medical
  • Dirección del fabricante
    Zipline Medical, 747 Camden Ave Ste A, Campbell CA 95008-4147
  • Empresa matriz del fabricante (2017)
    Zipline Medical Inc.
  • Source
    USFDA