Events

Retiro De Equipo (Recall) de Device Recall Tegaderm

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
    73237
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1036-2016
  • Fecha de inicio del evento
    2016-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143609
  • 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
    Dressing, wound, drug - Product Code FRO
  • Causa
    Misbranding; due to the presence of chg in the tegaderm picc/cvc dressing change convenience kit, which is not identified on the exterior labeling.
  • Acción
    Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@owens-minor.com . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.

Device

Device Recall Tegaderm
  • Modelo / Serial
    Kit #73775, Lot 213403
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to MO, NE and TX .
  • Descripción del producto
    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. || This kit is used by clinicians to change dressings
  • 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