Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BIOFLO 8F SINGLE PLASTIC FILLED Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to Snap lock connectors provided within implantable port kits...

Date: September 18, 2019
Company: Angiodynamics Inc. (Navilyst Medical Inc.)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics Inc. (Navilyst Medical Inc.) directly.

Affected Products

BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022

Quantity: 582

Why Was This Recalled?

Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Angiodynamics Inc. (Navilyst Medical Inc.)

Angiodynamics Inc. (Navilyst Medical Inc.) has 78 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report