Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2018 - (Recall #: Z-0076-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

Product Classification:

Class II

Date Initiated: July 24, 2018

Date Posted: October 17, 2018

Recall Number: Z-0076-2019

Event ID: 80913

Reason for Recall:

BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled

Status: Terminated

Product Quantity: 1 box

Code Information:

Lot Number: 5363172

Distribution Pattern:

US Nationwide in the state of IN.

Voluntary or Mandated:

Voluntary: Firm initiated