Devices

Device Recall Xcela PICC with PASV Valve Technology

  • Model / Serial
    Batch/Lots: 4721803, 4732391, 4767156, 4768679, 4784455, 4789995, 4809602, 4728559, 4752329, 4768072 & 4783738. Use By Date Range 2016-03-31 to 2016-10-31
  • 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
    Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, 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

3 devices with a similar name

Learn more about the data here

Device Recall Xcela PICC with PASV Valve Technology Catheter Kit
  • Model / Serial
    Batch/Lots: 4815673 Use By 2016-10-31
  • 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
    Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, 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
Device Recall Xcela PICC with PASV Valve Technology, IR145 Kit
  • Model / Serial
    Batch/Lots: 4712504, 4732394 & 4800179  Use By 2016-09-30
  • 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
    Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, 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
Device Recall Xcela PICC with PASV Valve Technology, Intermediate MST45 Kit
  • Model / Serial
    Batch/Lots: 4718004, 4783051, 4788340 & 4796128. Use By Date Range 2016-03-31 to 2016-08-31
  • 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
    Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 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