Events

Retiro De Equipo (Recall) de Device Recall Medikmark and Maxxim

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 Medikmark, Incorporated.

¿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
    29579
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1136-04
  • Fecha de inicio del evento
    2004-07-12
  • Fecha de publicación del evento
    2004-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34149
  • 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 tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
  • Acción
    Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.

Device

Device Recall Medikmark and Maxxim
  • Modelo / Serial
    reorder no. RS-2000: lot 304075; reorder no. SR-2000: lots 201106, 205173, 209014, 210017, 211084, 301059, 303069, 305096, 305143, 308044, 310136, 311136, 312059, 401132, 404160, 405062, 406018; reorder no. SD-2000: lot 204019
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: || a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000, 3600 Bur Wood Drive, Waukegan, IL 60085; || b)Medikmark Inc. Staple Removal Set, reorder no. SR-2000; 3600 Bur Wood Drive, Waukegan, IL 60085; || c) Maxxim Medical Staple Removal Kit, reorder no. SD-2000, Distributed by Maxxim Medical, Oldsmar, FL 34677.
  • Manufacturer
    Medikmark, Incorporated

Manufacturer

Medikmark, Incorporated
  • Dirección del fabricante
    Medikmark, Incorporated, 3600 Burwood Dr, Waukegan IL 60085-8399
  • Source
    USFDA