The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0719-2021·Announced 2020-12-30

B Braun APEX Compounding System Control Panel Module Recalled

B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.

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 software defect could lead to inaccurate drug compounding. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

B Braun Medical, Inc. is recalling 16 units of the APEX Compounding System Control Panel Module (REF: 601238, Product Code AX1000). The affected units are those with Software Version 1.0.5.57 or earlier. These devices are intended for intravascular administration to a patient.

The recall was initiated because the compounding system may not immediately interrupt the compounding 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 contact B Braun Medical for further instructions on how to proceed with the recall.

The recalled product

Product
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Manufacturer
B Braun Medical, Inc.
Category
Medical Device — Drug Compounding System
Hazard
Affected units
16

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 →

Related recalls

Same manufacturer · B Braun Medical, Inc.

See all →

Same hazard · software defect

See all →

Similar recalls