Events

Retiro De Equipo (Recall) de Device Recall Medline EZ Lubricating Jelly

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 MEDLINE IND.

¿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
    75948
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0984-2017
  • Fecha de inicio del evento
    2016-12-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151810
  • 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
    Lubricant, patient - Product Code KMJ
  • Causa
    Product was not sterilized. product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
  • Acción
    Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.

Device

Device Recall Medline EZ Lubricating Jelly
  • Modelo / Serial
    Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
  • Descripción del producto
    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). || Product Usage: || For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
  • Manufacturer
    MEDLINE IND

Manufacturer

MEDLINE IND
  • Dirección del fabricante
    MEDLINE IND, 3 Lakes Dr, Northfield IL 60093-2753
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA