Events

Retiro De Equipo (Recall) de Device Recall Hand 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
    76280
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1311-2017
  • Fecha de inicio del evento
    2017-01-11
  • Fecha de publicación del evento
    2017-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152854
  • 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
    The medtronic cover light handle disposable gloves of the custom aligned medical solutions (ams) kits were recalled because gloves may contain splits or holes compromising sterility.
  • Acción
    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 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 with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall Hand Pack
  • Modelo / Serial
    Lot number and expiration date  100610, 8/6/2018 84646, 5/12/2017 84692, 7/28/2017 84730, 5/18/2017 84851, 6/1/2017 84859, 2/28/2017 85509, 7/1/2017 86309, 8/26/2018 86748, 8/17/2018 86839, 8/2/2018 86937, 10/14/2017 87631, 10/5/2017 87866, 9/15/2018 88208, 4/6/2017 88209, 7/31/2017 88266, 10/29/2018 88267, 1/5/2020 88279, 1/3/2019 88402, 11/2/2017 88875, 10/31/2017 89734, 12/16/2017 94987, 3/21/2018 95112, 2/2/2018 96198, 2/10/2018 96608, 1/7/2018 97288, 2/7/2018 97796, 5/6/2018 98564, 3/19/2018 99383, 5/11/2018
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • Descripción del producto
    Hand Pack, part number AMS3640 || Hand Pack, part number AMS4213(A || Hand Pack, part number AMS4311(A || Hand Pack, part number AMS5343 || Hand Pack., part number PSS1843(A
  • 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