Retiro De Equipo (Recall) de Device Recall Stroke Fast Pack(TM)

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 Stryker Neurovascular.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Causa
    Stryker neurovascular has become aware that some 3-pack stroke fast packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
  • Acción
    Stryker notified their consignees by letter on 06/21/2017. The letter stated the following: This potentially impacts all 3-pack Stroke Fastpacks manufactured in the US. The product quality of the individual products in the Stroke Fastpack is not impacted. All units were manufactured to specification. We request that you read this notice carefully and complete the following actions: 1. Immediately check your internal inventory for impacted Catalog numbers. 2. Remove and discard the Stroke Fastpack carton sleeve. 3. Circulate this Field Safety Notice internally to all interested/affected parties. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete the form even if you no longer have any of the subject devices in your physical inventory. 8. Return the completed form to your nominated Stryker Representative or to


  • Modelo / Serial
    Lot Numbers: QPC40107530, QPC40107745, QPC40107814, QPC40110247
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
  • Descripción del producto
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, || Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
  • Manufacturer


  • Dirección del fabricante
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
  • Source