Events

Retiro De Equipo (Recall) de Device Recall American Surgical

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 American Surgical Company.

¿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
    73734
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1796-2016
  • Fecha de inicio del evento
    2016-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145367
  • 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
    Neurosurgical paddie - Product Code HBA
  • Causa
    Product packaging defective compromising sterility.
  • Acción
    American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: CustomerService@AmericanSurgical.com

Device

Device Recall American Surgical
  • Modelo / Serial
    Lot numbers:  2015/12 CD
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
  • Descripción del producto
    American Surgical Uniqcot 1/2" x 1.5" || Ref Number: 67-08 || Product Usage: || Neurosurgical and Nonneurosurgical Sponges
  • Manufacturer
    American Surgical Company

Manufacturer

American Surgical Company
  • Dirección del fabricante
    American Surgical Company, 45 Congress St, Salem MA 01970-5579
  • Empresa matriz del fabricante (2017)
    American Surgical Company Llc
  • Source
    USFDA