Retiro De Equipo (Recall) de HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure 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 Terumo BCT, 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
    78307
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0103-2018
  • Fecha de inicio del evento
    2017-10-20
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Causa
    The patient labels included in the bmac system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. the expiration noted was not beyond initiation date of the recall. since the product is noted as sterile, the clearance for k103340, k052925 and k991430 raises question if product was cleared with a sterility claim. further post-market follow-up will be required to assess the safety risk of the product.
  • Acción
    The firm initiated their recall by letter on 10/20/2017. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original procedure pack (white box), examine the label for catalog/lot numbers as shown in Figure C above. 2. If affected product is in your inventory, contact the Terumo BCT Customer Support Center at +1.877.3.FYI.BCT (U.S. Toll-Free +1.877.339.4228) or +1.303.231.HELP (+1.303.231.4357), Terumo BCT Europe N.V. at +32.2.715.0590, or your local Terumo BCT representative, and Terumo BCT will issue a Return Goods Authorization for product return. 3. Continue to use your unaffected product in accordance with the instructions for use. 4. Distribute this notification to all Harvest Bone Marrow Aspirate Concentrate (BMAC) System users within your organization. 5. IMPORTANT: Complete the attached acknowledgement and return it by fax or email to Terumo BCT by 27 October 2017. Your return of the acknowledgement is critical so we can confirm that you have received the recall notice.

Device

  • Modelo / Serial
    Lot 04A9938
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
  • Descripción del producto
    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Terumo BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA