Events

Retiro De Equipo (Recall) de Device Recall Breast 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-1277-2017
  • 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=152813
  • 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 Breast Pack
  • Modelo / Serial
    Lot number and expiration date  100106, 6/21/2019 100129, 9/30/2019 100132, 6/17/2019 100505, 10/6/2019 100805, 9/21/2019 85140, 7/28/2018 86315, 11/19/2018 87053, 9/12/2018 87623, 8/10/2019 87945, 10/29/2018 88185, 12/1/2018 88827, 10/10/2018 89726, 12/10/2018 94942, 1/10/2019 96754, 5/20/2019 97548, 5/19/2019 98079, 6/1/2019 98319, 6/24/2019 99056, 6/27/2019 99157, 6/15/2019 99711, 9/4/2019
  • 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
    Breast Pack, part number AMS3238(A || Breast Pack, part number AMS4419(A || Breast Pack, part number AMS4419(B || Breast Pack, part number AMS5750 || Breast Pack, part number AMS5750(A || Breast Pack, part number AMS6120 || Breast Pack, part number PSS1784(B || Breast Pack, part number PSS2272(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