Events

Retiro De Equipo (Recall) de Rifton Toddler 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 Community Products, LLC.

¿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
    49572
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0318-2009
  • Fecha de inicio del evento
    2008-09-12
  • Fecha de publicación del evento
    2008-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73829
  • 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
    Toddler Chair - Product Code INN
  • Causa
    Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. if a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.
  • Acción
    On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps. For questions or additional information, contact Rifton Equipment at 1-800-571-8198.

Device

Rifton Toddler Chair
  • Modelo / Serial
    Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD,  E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA,  E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA,  E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC,  E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE,  E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA,  E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA,  E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC,  E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD,  E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA,  E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB,  E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Spain and Great Britain.
  • Descripción del producto
    Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. || The product is used as a hip strap chair for children.
  • Manufacturer
    Community Products, LLC

Manufacturer

Community Products, LLC
  • Dirección del fabricante
    Community Products, LLC, 2032 Route 213, Rifton NY 12471
  • Empresa matriz del fabricante (2017)
    Community Products Llc
  • Source
    USFDA