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.

BodyGuard Microset REF A120-003XYVA Recalled by CME America, LLC Due to When using a specific tubing set with infusion...

Date: September 16, 2019
Company: CME America, 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 CME America, LLC directly.

Affected Products

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

Quantity: 69400 infusion sets

Why Was This Recalled?

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Where Was This Sold?

This product was distributed to 4 states: CA, OH, PA, TX

Affected (4 states)Not affected

About CME America, LLC

CME America, LLC has 47 total recalls tracked by RecallDetector.

Related Recalls

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