Class II — Potential Health Hazard

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

APEX Compounding System Control Panel Module Recalled by B Braun Medical, Inc. Due to There is the potential for the compounding system...

Date: November 23, 2020
Company: B Braun 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 B Braun Medical, Inc. directly.

Affected Products

APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

Quantity: 16 units

Why Was This Recalled?

There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B Braun Medical, Inc.

B Braun Medical, Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

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