Class II — Potential Health Hazard

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

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to NAMIC Fluid Management Convenience Kits contains a Fluid...

Date: January 18, 2018
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

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

Quantity: 38 units

Why Was This Recalled?

NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.

Where Was This Sold?

Recall conducted to end user level. Recall Notifications were delivered by Fed Express.

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