Events

Retiro De Equipo (Recall) de Device Recall Zee Clear Vinyl Medical Examination Gloves, Medium

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 LLC.

¿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
    60552
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0679-2012
  • Fecha de inicio del evento
    2011-11-15
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105790
  • 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
    Vinyl patient examination glove - Product Code LYZ
  • Causa
    The gloves fail to meet the performance requirements of 21 cfr 800.20 for leakage defects.
  • Acción
    Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.

Device

Device Recall Zee Clear Vinyl Medical Examination Gloves, Medium
  • Modelo / Serial
    Zee Part No.: 3061, lot number CZA04-22
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including California, Indiana, New York and Texas
  • Descripción del producto
    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 || Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • Dirección del fabricante
    Cypress Medical Products LLC, 1202 S Il Route 31, Mchenry IL 60050
  • Empresa matriz del fabricante (2017)
    Mckesson Corporation
  • Source
    USFDA