Events

Retiro De Equipo (Recall) de Device Recall Basic 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-1267-2017
  • 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=152802
  • 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 Basic Pack
  • Modelo / Serial
    Lot number and expiration date  100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018 86859, 8/18/2018 86939, 11/22/2018 87105, 9/15/2018 87269, 9/30/2018 87351, 9/15/2018 87447, 11/11/2018 87942, 9/23/2018 88172, 12/3/2018 88282, 9/7/2018 88368, 9/5/2018 88846, 12/11/2018 88887, 12/7/2018 89004, 10/8/2018 89160, 12/1/2018 89438, 11/22/2018 89512, 10/9/2018 89716, 1/9/2019 89743, 12/3/2018 89811, 12/1/2018 94572, 12/15/2018 94705, 12/15/2018 94751, 1/4/2019 94853, 1/27/2019 94935, 1/25/2019 95293, 1/26/2019 95412, 1/25/2019 95936, 1/11/2019 95974, 5/29/2019 96023, 1/16/2019 96255, 1/2/2019 96410, 3/7/2019 96566, 3/9/2019 96678, 5/24/2019 96913, 5/22/2019 97124, 5/12/2019 97410, 6/3/2019 97577, 5/1/2019 97780, 6/15/2019 98017, 6/29/2019 98312, 6/24/2019 98478, 6/29/2019 98502, 6/6/2019 98663, 6/28/2019 98633, 6/30/2019 99172, 6/12/2019 99581, 6/27/2019 99703, 9/27/2019 99843, 9/30/2019 99887, 9/11/2019 99913, 9/23/2019
  • 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
    Basic Pack, part number AMS1868(B || Basic Pack, part number AMS2608(A || Basic Pack, part number AMS3861 || Basic Pack, part number AMS4309 || Basic Pack, part number PSS1833 || Basic Pack, part number PSS1833(A || Basic Pack, part number PSS1848(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