Retiro De Equipo (Recall) de Device Recall DMI Rollator Transport 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 Briggs Medical Service Company d.b.a. Mabis.

¿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
    64774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0142-2015
  • Fecha de inicio del evento
    2014-06-05
  • Fecha de publicación del evento
    2014-10-28
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    There have been 5 customer reports of a 501-1018 series dmi rollator transport chair collapsing during use.
  • Acción
    The firm, Briggs Healthcare, sent "URGENT PRODUCT RECALL" letters dated July 28, 2014 to all distributors, retailers and consumers. The letters included instructions for distributors and dealers to: 1) examine their inventory; 2) quarantine any affected products; 3) cease distribution of the affected products; and, 4) complete and return the attached Customer Recall Acknowledgement Form. Distributors and dealers who further distributed the products were also instructed to notify their customers of this recall by forwarding a copy of the enclosed consumer notification letter and its associated documents. Distributors and dealers with questions about this recall can contact Briggs at 800-342-4426 (Monday - Friday, 8:00 AM - 6:00 PM EDT) or by e-mail at RecallCoord@briggscorp.com. The consumer-directed letter dated July 28, 2014 included instructions for consumers to examine their rollator transport chair to determine whether or not it is subject to the recall. If the consumer has the affected product, they should discontinue using it immediately and contact Briggs at 800--342-4426 (Monday - Friday, 8:00 AM - 6:00 PM EDT) or by e-mail at RecallCoord@briggscorp.com to arrange for the return of the product. Consumers will be given the option of receiving a cash voucher or a replacement product in exchange for the recalled product.

Device

  • Modelo / Serial
    A) Model Number: 501-1018-0700; UPC Code: 0-41298-10187-1; Lot Numbers: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211;    B) Model Number: 501-1018-2100; UPC Code: 0-41298-10182-6; Lots: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of:US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; and country of : Canada. ); FOREIGN: Canada
  • Descripción del producto
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; || Walking assistance device.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Briggs Medical Service Company d.b.a. Mabis, 1931 Norman Dr N, Waukegan IL 60085-6715
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA