Events

Retiro De Equipo (Recall) de Device Recall Stryker Evacuation Chair

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 Stryker Medical Division of Stryker Corporation.

¿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
    59112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3010-2011
  • Fecha de inicio del evento
    2011-06-28
  • Fecha de publicación del evento
    2011-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101240
  • 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
    Stretcher, hand-carried - Product Code FPP
  • Causa
    Some of the red release bars used during the time frame of 22 december 2010 through 31 january 2011 were reworked. the rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. the red release bars may bend to the degree that they permanently engage the track locking mechanism.
  • Acción
    The firm, Stryker Medical, sent an "Urgent-Medical Device Recall" letter dated June 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate the listed product; inspect each unit prior to use; return the enclosed post card to confirm receipt of this notification; if they have loaned or sold any of the chairs listed, forward a copy this letter to the new users and advise Stryker of new users names and locations, and if they have disposed of any of the affected chairs and they are no longer in use, advise Stryker of their obsolescence by providing them with the serial numbers. Stryker stated in the letter that, their goal is the timely upgrade of all affected units within the next 90 days. If you have any questions or concerns, please contact us at 800-STRYKER, option 2. Please reference RA-2011-027. Normal business hours are Monday-Friday 8am-5pm EST.

Device

Device Recall Stryker Evacuation Chair
  • Modelo / Serial
    Model 6254, Lot numbers 110143822, 110143823, 110143824, 110143825, 110143826, 110143827, 101240120, 101240121, 101240122, 110142843, 110143758, 101240123, 101240124, 101240125, 101240126, 101240441, 101240442, 101240443, 101240863, 110142646, 110142632, 110142619, 110143756, 101240880, 110143801, 101240850, 101240851, 101240852, 101240853, 101240854, 101240855, 110143828, 110143829, 110143830, 110143831, 101241171, 101240127, 101240128, 101240129, 101240130, 101240131, 101240868, 101240892, 101240893, 101240894, 101240895, 101240896, 101240897, 101240898, 101240119, 110142620, 110143282, 110143283, 110143284, 110143281, 101240132, 101240133, 101240134, 101240135, 101240136, 101240137, 101240138, 101240139, 101240140, 101240141, 101240142, 101240143, 101240144, 101240858, 101240859, 101240860, 101240861, 101240862, 110143753, 110143754, 110143755, 101239046, 101239047, 101239048, 110142616, 110142617, 110142618, 101240145, 101240146, 110142625, 101241172, 101241173, 101241174, 101241175, 101241176, 101241177, 110142624, 101240870, 110142652, 110142653, 110142648, 110142649, 110142650, 110142651, 101241444, 101241445, 101241446, 101241447, 101241448, 101241449, 101240437, 101240438, 101240439, 101240440, 101241863, 101241864, 101241865, 101241866, 101240864, 101240865, 101240866, 101240867, 110142647, 110143222, 110142633, 110142634, 110142844, 110142621, 101240100, 101240101, 101240102, 101240103, 101240104, 101240105, 101240106, 101240107, 101240108, 101240109, 101240110, 101240111, 101240112, 101240113, 101240114, 101240881, 101240882, 101240883, 101240884, 110143832, 110143835, 110143797, 110143798, 110143799, 110143800, 110143750, 110143751, 110143757, 101240869, 110143802, 110143803, 110143804, 110143793, 110143794, 110143795, 110142630, 110142631, 101239030, 101239031, 101239032, 101239033, 101239034, 101239035, 101239036, 101239037, 101239038, 101239039, 101239040, 101239041, 101239042, 101239043, 101239044, 101239045, 101240416, 101240417, 101240418, 101240419, 101240420, 101240421, 101240422, 101240423, 101240424, 101240425, 101240426, 101240427, 101240428, 101240429, 101240430 01240431, 101240432, 101240433, 101240434, 101240435, 101241170, 101241152, 101240838, 101240839, 101240840, 101240841, 101240842, 101240843, 101240844, 101240845, 101240846, 101240408, 110143796, 101240118, 110142840, 110142841, 110142842, 101240409, 101240410, 101240411, 101240412, 101240413, 101240414 and 101240415.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • Descripción del producto
    Stryker Evacuation Chair Model 6254 || It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA