FDAFDA · Alimentos y medicamentos·N.º oficial Z-1984-2016
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Publicado el 22 de junio de 2016 · Inicio del retiro: 14 de marzo de 2016
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
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Navilyst Medical, Inc., an AngioDyamics Company
- Distribuidor
- Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
- Lote
- Batch/Lots: 4824806 Use By 2016-10-31
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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