Recall Z-1981-2016— Navilyst Medical, Inc., an AngioDyamics Company

Name: FDA recall Z-1981-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-14

Class II · Terminated

Class II FDA medical device recall by Navilyst Medical, Inc., an AngioDyamics Company, initiated 2016-03-14, terminated 2018-06-11. It names one FDA 510(k) clearance: K021704. Product: BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, 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. Reason: 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..

Recalling firm: Navilyst Medical, Inc., an AngioDyamics Company
Classification: Class II
Status: Terminated
Initiated: 2016-03-14
Terminated: 2018-06-11
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K021704 — VAXCEL PICC WITH PASV VALVE TECHNOLOGYCatheter Innovations, Inc.·cleared 2002-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, 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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.