Agency classClass IIOur severity:High FDA (Devices)·Z-0717-2021·Announced 2020-12-30

B Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues

B Braun Medical is recalling 248 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device intended for intravascular administration where a defect could lead to inaccurate drug dosing. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

B Braun Medical, Inc. is recalling 248 units of the APEX Compounding System Control Panel Module (REF: 601224, Product Code AX1000). The affected units are those with Software Version 1.0.5.57 or earlier. The product is intended for intravascular administration to a patient.

The recall was initiated because the compounding system may not immediately interrupt the process or alert the user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This failure could result in a compounded drug that does not meet the specified accuracy range for an individual ingredient.

The affected units were distributed nationwide in the United States, including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, and WA. Healthcare facilities and users should identify affected units by checking the software version and contact B Braun Medical for further instructions.

The recalled product

Product: APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Manufacturer: B Braun Medical, Inc.
Category: Medical Device — Compounding System
Hazard: inaccurate-dosing
air-bubble
Affected units: 248

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All APEX Compounding System with Software Version 1.0.5.57 or earlier

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by B Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · B Braun Medical, Inc.

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