Retiro De Equipo (Recall) de Vital Signs

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 Vital Signs Devices, a GE Healthcare Company.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Oxygen Administration Kit - Product Code OGL
  • Causa
    Povidone iodine pads included in the vital signs broselow pediatric emergency kit may be contaminated with elizabethkinga meningoseptica.
  • Acción
    GE Healthcare sent a recall letter/return response form dated October 17, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to not use the affected product, isolate and discard all affected product. Fill out the attached Confirmation form and fax back to 800-535-7923 per the instructions to obtain replacement Busse IV Start Kits. Also, consignees were instructed to return the attached response form even if no recalled product was in their inventory. If they forwarded any affected product to any other healthcare institutions, they should forward a copy of the letter to those institutions. For any questions regarding this recall call 1-800-932-0760.


  • Modelo / Serial
    Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor.  Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN  Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV  Lot codes of the Broselow Kits and Intra Venous Modules that contain affected Povidone Iodine Pads: 2008: 228F-366F 2009: 010K-258K and 010L-258L
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide and Foreign
  • Descripción del producto
    Broselow/Hinkle Pediatric Emergency System || Vital Signs Inc. || 20 Campus Road || Totowa, NJ 07512 USA || The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
  • Manufacturer


  • Dirección del fabricante
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Empresa matriz del fabricante (2017)
  • Source