Class II — Potential Health Hazard

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

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Recalled by CME America, LLC Due to The filter installed onto the tube set may...

Date: January 14, 2020
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 For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

Quantity: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201

Why Was This Recalled?

The filter installed onto the tube set may have the incorrect pore size.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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