Retiro De Equipo (Recall) de Device Recall MediChoice DualRelease Folding Walker

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 Owens & Minor Distribution, 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
    68780
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0416-2015
  • Fecha de inicio del evento
    2014-06-25
  • Fecha de publicación del evento
    2014-11-20
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-01-06
  • 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
    Product wheels may be too loose, too tight, or fall off.
  • Acción
    Customers were notified via letter and email by June 27, 2014. to take the following actions: 1. Designate a quarantine location in the DC for the recalled lots and serial numbers. 2. Label this area very clearly as "RECALLED PRODUCT IN QUARANTINE". 3. Clearly segregate the area to prevent the product from being moved or handled and to further designate that the product is in quarantine. 4. Record each case lot# or walker serial number if the product is out of the case on the recall inventory report. 5. Label each unit in the quarantine area with a label that clearly states RECALLED PRODUCT IN QUARANTINE. 6. Conduct a daily inventory verification check using to ensure the inventory still remains in quarantine. In addition, please forward a copy of this letter to hospital personnel in a position to notify patients who may have received and been discharged with a walker from the lots and serial numbers identified above. Hospital Customers: Contact your local DC Customer Service Representative who will assist in returning and replacing the recalled walker. Patients Who May Have Received a Recalled Walker from a Hospital: Contact Owens & Minor Mainstreet Customer Service at 1-800-818-6664 who will assist you in returning and replacing a walker.

Device

  • Modelo / Serial
    Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520;  1306CA07A 1307001521-1307002184;   1307CA07A 1307002185-1307002888;   1309CA07A 1307002889-1307003292;   1310CA07A 1307003293-1307004044;   1311CA07A 1307004045-1307004752;  1312CA07A 1307004753-1307005236;
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.
  • Descripción del producto
    MediChoice Dual-Release Folding Walker with 5" wheel
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Owens & Minor Distribution, Inc., 9120 Lockwood Blvd, Mechanicsville VA 23116-2015
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA