Navilyst Medical, Inc., an AngioDyamics Company: Medical Device Recall in 2016 - (Recall #: Z-1984-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , 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

Product Classification:

Class II

Date Initiated: March 14, 2016

Date Posted: June 22, 2016

Recall Number: Z-1984-2016

Event ID: 73598

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

Batch/Lots: 4824806 Use By 2016-10-31

Distribution Pattern:

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

Voluntary or Mandated:

Voluntary: Firm initiated