Events

Retiro De Equipo (Recall) de Device Recall Kimberly Clark Ultra 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
    57535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0920-2011
  • Fecha de inicio del evento
    2010-12-23
  • Fecha de publicación del evento
    2011-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96481
  • 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 Gown - Product Code FYA
  • Causa
    Product was not properly sterilized.
  • Acción
    Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.

Device

Device Recall Kimberly Clark Ultra Surgical Gown
  • Modelo / Serial
    Product code (Large Surgical Gowns): 95111-35, Case Lot Numbers: AH0319YL0, AH0319YLI, AH0319YM4, AH0319YLH, AH0319YLJ, AH0319YM3, AH0320YMD, AH0320YME, AH0320YMF, AH0320YMG, AH0320YMN, AH0320YMM, AH0320YMH, AH0320YN0, AH0320YNC, AH0320YND, AH0320YNJ, AH0320YNI, AH0320YNK; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
  • Descripción del producto
    Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

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