FDAFDA · Alimentos y medicamentos·N.º oficial Z-2218-2012
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Publicado el 22 de agosto de 2012 · Inicio del retiro: 20 de junio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Terumo Cardiovascular Systems Corporation
- Distribuidor
- US Nationwide Distribution - including the state of New York
- Lote
- catalog number: 16401 and serial number: 2001, 2002, and 2003.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States