Events

Retiro De Equipo (Recall) de Device Recall Cataract Kit

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 Windstone Medical Packaging, 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
    76774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1783-2017
  • Fecha de inicio del evento
    2017-03-16
  • Fecha de publicación del evento
    2017-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154148
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Causa
    Ams custom kits containing medtronic covidien curity eye pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
  • Acción
    AMS sent an Urgent Medical Device Recall letter dated March 16, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.

Device

Device Recall Cataract Kit
  • Modelo / Serial
    Lot numbers: 76819 76820 78070 78533 78534 78535 79189 79972 80673 80674 80696 81600 82230 83093 83094 83585 83899 84580 85193 86565 86956 87679 88237 88915 88917 89946 95370 95574 95575 96215 96720 97384 97669 99621 99816 99881 101220
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
  • Descripción del producto
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. || Product packaged in a convenient manner for use in a general clinical procedure
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.
  • Dirección del fabricante
    Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
  • Empresa matriz del fabricante (2017)
    Windstone Medical Packaging Inc.
  • Source
    USFDA