Events

Retiro De Equipo (Recall) de Device Recall ULTRA Fabric Reinforced Surgical Gown

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 Kimberly-Clark Corporation.

¿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
    62577
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2425-2012
  • Fecha de inicio del evento
    2010-12-31
  • Fecha de publicación del evento
    2012-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111080
  • 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
    Drape, surgical - Product Code KKX
  • Causa
    The impacted product was not intended for commercial distribution to end users.
  • Acción
    Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product according to their facility procedures. And to review their distribution records to identify all customers who were shipped any of the impacted products. Notify each of their customers who were shipped any of the impacted products by sending them a copy of the attached Customer Letter with the Customer Withdrawal Response Form. A minimum of three (3) attempts to contact each non-responding customer within interval of approximately four to six weeks will be performed. Once all customers who were notified have responded or after approximately four weeks after the third attempt to contact the last non-responder, a recall Termination will be initiated If your Kimberly-Clark Representative has not already contacted you, please contact the Ultra Fabric Reinforce surgical Gown Coordinator at (770) - 587-7700.

Device

Device Recall ULTRA Fabric Reinforced Surgical Gown
  • Modelo / Serial
    Product Code: 95221-35, Unit Code: 90372
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
  • Descripción del producto
    ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. || The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Dirección del fabricante
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA