Class II — Potential Health Hazard

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

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Recalled by RGI Medical Manufacturing, Inc. Due to Problem with low adhesion of the tubing to...

Date: March 28, 2014
Company: RGI Medical Manufacturing, 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 RGI Medical Manufacturing, Inc. directly.

Affected Products

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

Quantity: 19,200 units.

Why Was This Recalled?

Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RGI Medical Manufacturing, Inc.

RGI Medical Manufacturing, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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