Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit

  • Modèle / numéro de série
    Batch/Lots: 4773627, 4780053 & 4782468. Use By Date Range 2016-05-31 to 2016-07-31
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Description du dispositif
    BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 || 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
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Navilyst Medical, Inc., an AngioDyamics Company, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Société-mère du fabricant (2017)
  • Source
    USFDA