Events

Retiro De Equipo (Recall) de Device Recall Cataract Pack

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-1785-2017
  • 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=154150
  • 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 Pack
  • Modelo / Serial
    Lot numbers:  63660 64459 65292 65897 65898 66764 66765 66770 67186 67187 67403 67867 67868 68184 68858 69648 69649 71075 71076 71077 71472 71950 71951 71952 72496 72497 72498 74246 74623 74985 75511 75512 75583 75904 76936 77245 77481 77591 78638 82162 82430 82583 82952 82954 82955 82956 82957 83400 83401 83855 83856 83857 83858 83904 84167 85095 85475 85944 86233 86234 86235 86593 86788 86925 87176 87552 87616 87721 88020 88234 88708 88709 89240 89643 89978 94699 95340 95341 95671 95873 96086 96372 96651 96847 96848 97636 97905 97985 98071 98228 98229 98585 98586 98587 98775 98826 98977 99442 99443 99587 99803 100091 100092 100155 100312 100313 100698 100699 101691 101692 101926 101927 102049 102139 102361
  • 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 Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. || 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