Class II — Potential Health Hazard

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

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term Recalled by Access Vascular, Inc Due to Label with the incorrect component listed on the...

Date: December 22, 2022
Company: Access Vascular, Inc
Status: Ongoing
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 Access Vascular, Inc directly.

Affected Products

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

Quantity: 445 units

Why Was This Recalled?

Label with the incorrect component listed on the inner kit Tyvek header bag

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Access Vascular, Inc

Access Vascular, Inc has 8 total recalls tracked by RecallDetector.

Related Recalls

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