Class II — Potential Health Hazard

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

Arctic Sun Temperature Management System Recalled by Bard Medical Division Due to An improper wiring connection on the chiller assembly...

Date: June 13, 2018
Company: Bard Medical Division
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 Bard Medical Division directly.

Affected Products

Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.

Quantity: 5608 Units Total

Why Was This Recalled?

An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bard Medical Division

Bard Medical Division has 5 total recalls tracked by RecallDetector.

Related Recalls

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