Events

Retiro De Equipo (Recall) de Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.

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 Infantino 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
    67582
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1313-2014
  • Fecha de inicio del evento
    2014-01-06
  • Fecha de publicación del evento
    2014-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125764
  • 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
    Ring, Teething, Non-Fluid Filled - Product Code MEF
  • Causa
    Infantino initiated this voluntary recall of all lots of infantino squeeze & teethe monkey, "go gaga squeeze & teethe coco the monkey", model number 206-647, because the tail of the monkey may pose a choking hazard to young children.
  • Acción
    Infantino, LLC initiated this recall by notifying its customer on January 6, 2014 and Consumer Product Safety Commission (CPSC) posted the press release on 02/20/2014. CPSC posted the press release on the CPSC website. The CPSC recall press release dated February 20, 2014 informed consumers should stop using this product unless otherwise instructed and it is illegal to resell or attempt to resell a recalled consumer product. The CPSC press release contains a Recall Summary with the name of product, hazard, remedy, consumer contact information "Infantino toll-free at (888) 808-3111 between 8 a.m. and 4 p.m. PT Monday through Friday or online at www.infantino.com and click on Recall Information on the home page.", Recall Details on the number of units, description, incidents/injuries, remedy, sold exclusively at Target stores nationwide, Importer, Manufactured in China, and CPSC Consumer Information Hotline and Media Contact. The CPSC press release also contained photos of the product. Infantino, LLC also posted on their company website information on this recall.

Device

Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled...
  • Modelo / Serial
    Model # 206-647. All lot numbers are included in the scope of the recall
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US nationwide.
  • Descripción del producto
    Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring.
  • Manufacturer
    Infantino LLC

Manufacturer

Infantino LLC
  • Dirección del fabricante
    Infantino LLC, 4920 Carroll Canyon Rd Ste 200, San Diego CA 92121-3735
  • Source
    USFDA