Events

Retiro De Equipo (Recall) de Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per 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 Medical Action Industries 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
    80147
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2043-2018
  • Fecha de inicio del evento
    2017-12-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164683
  • 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
    Fiber, medical, absorbent - Product Code FRL
  • Causa
    Product sterility potentially compromised.
  • Acción
    On December 11, 2017, the firm sent letters to their consignee informing them to: Immediately examine your inventory and quarantine all product subject to this recall notification. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Replacement product should be available within the next two weeks. Should you have immediate replacement needs in the interim, we do have sufficient inventory of AVID265, Blue OR Towel Non X-Ray Detectable (4 Towels per Pack), available for immediate distribution. Your assistance is appreciated and necessary to prevent any unintended use of affected product. Please complete and return the enclosed response form as soon as possible. For further questions, please call (828_ 338-7604.

Device

Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)
  • Modelo / Serial
    Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
  • Descripción del producto
    Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile || This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Dirección del fabricante
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Empresa matriz del fabricante (2017)
    Owens & Minor Inc
  • Source
    USFDA