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Navilyst Medical, Inc., an AngioDyamics Company recalls BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xc
Recalled June 22, 2016 · FDA recall Z-1982-2016 · Navilyst Medical, Inc., an AngioDyamics
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. · FDA Class II
Units
438 units
Sold at
Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Description
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.
Product
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, 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(s)
Navilyst Medical, Inc., an AngioDyamics Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →