Events

Retiro De Equipo (Recall) de Device Recall 500 mL InfoV.A.C. Canister

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 KCI USA, Inc..

¿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
    49110
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2440-2008
  • Fecha de inicio del evento
    2008-07-29
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72794
  • 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
    Ac-Powered Suction Apparatus - Product Code JCX
  • Causa
    The port on the 500ml infov.A.C. canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
  • Acción
    Urgent - Medical Device Recall letters were sent within the US on 07/29/08 via UPS next day delivery service and a return receipt was maintained to demonstrate delivery of the recall to all consignees. Additionally, firm is sending representatives into accounts which received more than three sales units of canisters and to all foreign consignee locations to facilitate quarantine and replacement of affected stock. Consignees asked to confirm that adequate flow is being delivered and that the dressing is being drawn down for those patients currently using the InfoV.A.C. Canisters. Also, consignees are to locate and quarantine all packaged 500 ml canisters without the green inspection stickers from within the affected lot numbers in their inventory. A KCI Rep will contact them to help facilitate this process. Consignees are to complete and return the Recall Acknowledgement and Inventory Accounting Form. KCI will replace any affected product at their facility and arrange for the return of any affected product.

Device

Device Recall 500 mL InfoV.A.C. Canister
  • Modelo / Serial
    For M8275071/5: 20063928   For M8275071/10: 20062500, 20063927, 20063927.15108D, 20063930, 20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123, 20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941, 20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and 20094198
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.
  • Descripción del producto
    500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Dirección del fabricante
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA