Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Alaris Medley LVP Bezel Assembly. Intended use to hold platen Recalled by Elite Biomedical Solutions LLC Due to Administration of inappropriate quantities of fluid can result,...

Date: June 3, 2015
Company: Elite Biomedical Solutions LLC
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 Elite Biomedical Solutions LLC directly.

Affected Products

Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

Quantity: 346 units

Why Was This Recalled?

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Elite Biomedical Solutions LLC

Elite Biomedical Solutions LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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