Events

Retiro De Equipo (Recall) de Device Recall Baxter Healthcare Corp.

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 Apatech Limited.

¿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
    74125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1922-2016
  • Fecha de inicio del evento
    2015-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146367
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    Baxter healthcare is issuing a voluntary recall for all lots of actifuse abx and actifuse mis system products with expiry before july 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
  • Acción
    The firm, Baxter, sent an "Urgent Product Recall Notification" letter dated 8/18/2015 and a follow-up letter date 4/29/2016 to consignees via FedEx, overnight mail. Baxter also notified affected customers by phone. The letters described the product, problem and actions to be take. Baxter Healthcare has instructed customers to do the following: 1. Locate and remove all affected product from their facilities. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. Complete the attached customer reply form and return it to Baxter by either fax it to 224-270-5457 or scanned e-mail to fca@baxter.com. 4. If you distribute this product to other facilities or departments with your institution, notify all affected parties of this communication. For general questions regarding this communication, please call Baxter's Therapeutic Medical Affairs at 805-657-0007 or 862-432-7941.

Device

Device Recall Baxter Healthcare Corp.
  • Modelo / Serial
    Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
  • Descripción del producto
    Actifuse ABX/Actifuse MIS System || A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
  • Manufacturer
    Apatech Limited

Manufacturer

Apatech Limited
  • Dirección del fabricante
    Apatech Limited, 370 Centennial Ave, Elstree United Kingdom
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA