Devices

Device Recall BioFlo PICC with ENDEXO and PASV Valve Technology, MST70 Kit

  • Model / Serial
    Batch/Lots: 4720503, 4778382, 4799263, 4824908, 4744027, 4752337, 4762746, 4786750, 4797579, 4824615, 4831212 & 4841018. Use By Date Range 2016-03-31 to 2016-12-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, 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
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event

Manufacturer

Navilyst Medical, Inc., an AngioDyamics Company
  • Manufacturer Address
    Navilyst Medical, Inc., an AngioDyamics Company, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA