FDAFDA · Alimentos y medicamentos·N.º oficial Z-0714-2017
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring
Publicado el 14 de diciembre de 2016 · Inicio del retiro: 8 de junio 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
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Distribuidor
- Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
- Lote
- Lot #: 4941411
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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