Events

Retiro De Equipo (Recall) de Device Recall McKesson MediPak Elastic Bandage, Premium, Sterile

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 Cypress Medical Products, Ltd..

¿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
    30550
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0368-05
  • Fecha de inicio del evento
    2004-12-02
  • Fecha de publicación del evento
    2004-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36090
  • 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
    Bandage, Elastic - Product Code FQM
  • Causa
    The elastic bandages which are labeled sterile have a lack of assurance of sterility.
  • Acción
    Cypress Medical recalled the elastic bandages fro McKesson Medical-Surgical on 12/1/04 by telephone call and letter. McKesson was requested to sub-recall the product from their customers, which they did by letter dated 12/2/04.

Device

Device Recall McKesson MediPak Elastic Bandage, Premium, Sterile
  • Modelo / Serial
    Product Numbers 16-1033-2-STR, 16-1033-3-STR, 16-1033-4-STR, 16-1033-6-STR; lot numbers 3001 through 40999
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA.
  • Descripción del producto
    McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: || Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide
  • Manufacturer
    Cypress Medical Products, Ltd.

Manufacturer

Cypress Medical Products, Ltd.
  • Dirección del fabricante
    Cypress Medical Products, Ltd., 1202 S. Rte 31, McHenry IL 60050
  • Source
    USFDA