Events

Retiro De Equipo (Recall) de Device Recall General Surgery Packs

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
    73743
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1870-2016
  • Fecha de inicio del evento
    2016-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144842
  • 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
    Kit, i.V. Start - Product Code LRS
  • Causa
    These packs contain item #4037 kerlix x-ray detectable laparotomy sponges which were recalled by medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
  • Acción
    Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 2016, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remaining inventory. Consignees should return the Reply Form via fax at 407-865-7456 or call 321-527-7714 for any questions about this recall.

Device

Device Recall General Surgery Packs
  • Modelo / Serial
    lot 56402, 57255, 60542, and 61506
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to Louisiana and Montana.
  • Descripción del producto
    General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. || There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
  • 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