Events

Retiro De Equipo (Recall) de Device Recall Roscoe Transport Rollator

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 Roscoe Medical 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
    69367
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0204-2015
  • Fecha de inicio del evento
    2014-10-01
  • Fecha de publicación del evento
    2014-11-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130304
  • 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
    Walker, mechanical - Product Code ITJ
  • Causa
    The caster may separate completely from the device frame causing injury to user.
  • Acción
    The firm, Roscoe Medical, issued a "URGENT RECALL NOTICE-Timely Response Required" Quarantine Communication to customers between 09/08/2014 and 09/10/2014. The notice identified affected products as 30194, serial number range MH140407092MH140407291, the problem and actions to be taken. The customers were instructed NOT to use this product and to destroy any affected product that may be in their inventory/control; immediately complete and return the attached Recall Response Form/Certificate of Destruction to Roscoe Medical- "Transport Rollator Recall" within 15 days of receipt of the recall notification via fax to (440) 572-4261 or email: corporate@roscoemedical.com, even if you do not have any affected product; and notify your customers immediately of this product recall. Should you have any questions, contact Roscoe Medical Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST - 5:00 pm EST.

Device

Device Recall Roscoe Transport Rollator
  • Modelo / Serial
    30194, Roscoe Transport Rollator, Blue 30192, Roscoe Transport Rollator, Burgundy MH140401502-MH140401890 MH140500217-MH140500466 MH140406602-MH140406891 MH140407092-MH140407291
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.
  • Descripción del producto
    Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. || Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)
  • Manufacturer
    Roscoe Medical Inc

Manufacturer

Roscoe Medical Inc
  • Dirección del fabricante
    Roscoe Medical Inc, 21973 Commerce Pkwy, Strongsville OH 44149-5558
  • Empresa matriz del fabricante (2017)
    Compass Health Brands Corp
  • Source
    USFDA