Events

Retiro De Equipo (Recall) de Medline Latex Free Labor Kit & Postpartum CDSLF

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 Medline Industries 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
    49107
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0017-2009
  • Fecha de inicio del evento
    2008-08-04
  • Fecha de publicación del evento
    2008-10-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73461
  • 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
    Cesarean Section Kit - Product Code OHM
  • Causa
    The latex free labor & delivery packs contain a latex nuk pacifier. the pacifier is packaged separately and offers no risk of exposure of latex particles to other components of the pack.
  • Acción
    Recall letters dated 8/4/08 were sent to the direct accounts on the same date, informing them that the labor and delivery packs were labeled Latex Free, but contained a Latex Nuk pacifier. The letters were customized for each account, listing the specific affected reorder numbers and lot numbers shipped to each account. The accounts were requested to immediately check their stocks for the affected lot numbers and quarantine the affected product found. The accounts were given three options: A) Attach the enclosed stickers to the packs so that the user is aware of the latex Nuk pacifier, B) Call Medline to receive replacement non-latex pacifiers, but also place the stickers on the packs, C) Return the packs to Medline for replacements. The accounts were requested to complete the enclosed response form, indicating which option the account selected and whether they needed any additional stickers, and fax the form back to Medline at 847-643-4482 by 8/18/08. Any questions were directed to Kathy Dunne at 1-866-359-1704.

Device

Medline Latex Free Labor Kit & Postpartum CDSLF
  • Modelo / Serial
    LABOR KIT & POSTPARTUM CDS-LF reorder # CDS830074D, lots 05HB0427, 05IB0654, 05IB1857, 05KB0229, 06AB1244, 06BB0159, 06CB0593, 06CB1926, 06CB2197, 06FB0015, 06FB0476, 06GB0916, 06HB0704, 06HB2791, 06IB1312, 06IB1922, 06IB2566, 06KB0020, 06KB1042, 06KB2322, 06LB2102, 07AB0437, 07BB2798, 05AD3274, 05BD4131, 05CD3200, 05FD2631;  reorder #CDS830074F, lots 07DB1578, 07GB1509, 07IB0792, 07JB0627, 07JB1829, 07LB0150, 07LB0508, 08BB0151;
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of Alabama, Arizona, Georgia, Missouri, Nevada, New Jersey, and Washington.
  • Descripción del producto
    Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA