Navilyst Medical, Inc., an AngioDyamics Company: Medical Device Recall in 2016 - (Recall #: Z-1986-2016)

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 Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, 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-1986-2016

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: 10 units

Code Information:

Batch/Lots: 4806370 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