FDA-Device2016-06-22Class II
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 lume
Navilyst Medical, Inc., an AngioDyamics Company
Hazard
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.
Sold states
Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Affected count
376 units
Manufactured in
10 Glens Falls Tech Park, Glens Falls, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1983-2016Don't want to check this manually?
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