Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

ThermoFlo 1 HME Recalled by Arc Medical Inc Due to Outer shipping carton was marked with an incorrect...

Date: February 19, 2015
Company: Arc 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 Arc Medical Inc directly.

Affected Products

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Quantity: 1810 units

Why Was This Recalled?

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Where Was This Sold?

This product was distributed to 2 states: CA, NC

Affected (2 states)Not affected

About Arc Medical Inc

Arc Medical Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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