Events

Retiro De Equipo (Recall) de Device Recall KimberlyClark, Three Quarter Drape

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
    59161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2836-2011
  • Fecha de inicio del evento
    2011-06-06
  • Fecha de publicación del evento
    2011-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101449
  • 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
    Surgical Drape - Product Code KKX
  • Causa
    Metal shavings were found within the folded portion of the surgical drape.
  • Acción
    Kimberly-Clark Corporation sent an "Urgent: Voluntary Product Recall" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011. The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.

Device

Device Recall KimberlyClark, Three Quarter Drape
  • Modelo / Serial
    Product Code: 79147 Lot numbers: AC1080052, AC1093104, AC1094061, AC1098193, AC1099073, AC1099213, AC1099074, AC1100074, AC1105054, AC 1124031, AC1124092, AC1126173, AC 1127013, AC 1128153, AC1129031, AC1129062, AC1130011, AC1130092, AC1082042, AC1089111, AC1102021 AC1102141, AC1103031, AC1104101, AC1106103, AC1106164, AC1107084, AC1121184, AC1122071, AC1122192, AC1123012, AC1125111, AC1131082, AC1131092, AC1131151, AC1134133.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.
  • Descripción del producto
    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, || Surgical drape.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

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