Events

Retiro De Equipo (Recall) de Stryker Twostage and threestage I.V. poles

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
    72466
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0344-2016
  • Fecha de inicio del evento
    2015-10-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141155
  • 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
    Stand, infusion - Product Code FOX
  • Causa
    It was identified by a customer complaint that some i.V. poles were retracting/lowering from an extended position to the low height unexpectedly. an investigation was initiated which identified that the i.V. latch housing was nonconforming. potential hazards: " suspended i.V. pole retracts unexpectedly " suspended i.V. pole retracts unexpectedly with pump/bags attached.
  • Acción
    On 10/13/2015, URGENT MEDICAL DEVICE NOTIFICATION letters were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).

Device

Stryker Twostage and threestage I.V. poles
  • Modelo / Serial
    Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action is limited to I.V. Poles distributed between 01/07/2014 - 06/24/2014.  The following I.V. Pole option numbers come affixed to beds and stretchers:  Manufacturer Model Number and Product Description 2035-112-010; Head End Left, 2 Stage I.V. Pole 2035-113-011; Head End Right, 2 Stage I.V. Pole 0785-035-101; 26", 2 Stage IV Pole Assembly 0785-035-200; 26", 3 Stage IV Pole Assembly 0785-035-300; 30", 3 Stage IV Pole Assembly 0785-035-401; 30", 2 Stage IV Pole Assembly   The following I.V. Pole option numbers ship as service kits.  Manufacturer Service Kit Number and Product Description 1105-035-368; 30" IV POLE 2 STAGE HE PR 1105-035-367; 30" IV POLE 2 STAGE HE PL 1105-035-343; 30" IV POLE 2 STAGE FE PR 1105-035-341; 30" IV POLE, 2 STAGE HE, PR 1105-035-340; 30" IV POLE, 2 STAGE FE, PL 1105-035-338; 30" IV POLE, 2 STAGE FE, PL 1040-035-338; 2-STAGE IV POLEHEAD LT30" ZM 0785-035-340; 2-STAGE IV POLE,HEAD LT, 30" 0785-035-341; 2-STAGE IV POLEHEAD RT 30" 0785-035-343; 2-STAGE IV POLE,FOOT RT, 30" 1105-035-344; 30" IV POLE, 3 STAGE FE, PL 1105-035-342; 30" IV POLE, 3 STAGE HE, PL 1105-035-339; 30" IV POLE, 3 STAGE FE, PR 1105-035-369; 30" IV POLE, 3 STAGE HE, PL 1105-035-366; 30" IV POLE, 3 STAGE HE, PR 0785-035-339; 3-STAGE IV POLE,FOOT RT, 30" 0785-035-342; 3-STAGE IV POLE,HEAD LT, 30" 1105-035-644; 26" IV POLE, 3 STAGE FL 1105-035-642; 26" IV POLE, 3 STAGE HL 1105-035-639; 26" IV POLE 3 STAGE FR 1105-035-637; 26" IV POLE, 3 STAGE HR 0785-035-637; 3-STAGE IV POLE,HEAD RT, 26" 0785-035-639; 3-STAGE IV POLE,FOOT RT, 26" 0785-035-642; 3-STAGE IV POLE,HEAD LT, 26" 1105-035-643; 26" IV POLE, 2 STAGE FR 1105-035-641; 26" IV POLE, 2 STAGE HR 1105-035-640; 26" IV POLE, 2 STAGE FL 1105-035-638; 26" IV POLE, 2 STAGE HL 0785-035-638; 2-STAGE IV POLE,HEAD LT, 26" 0785-035-640; 2-STAGE IV POLE,FOOT LT, 26" 0785-035-641; 2-STAGE IV POLE,HEAD RT, 26" 0785-035-643; 2-STAGE IV POLE,FOOT RT, 26" 2035-112-000; IV POLE - 2 STAGE H/E 2035-113-000; DUAL H/E 2 STAGE IV POLE OPT
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.
  • Descripción del producto
    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. || models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X || and 1125XE.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA