Recall – Software error can result in inaccurate drug compounds

Company: B Braun Medical, Inc.
Date of Enforcement Report: 12/30/2020
Class II


APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 – Product Usage: intended for intravascular administration to a patient.

Recall Number: Z-0717-2021


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.


B Braun Medical, Inc. on 11/23/2020. Voluntary:  Firm Initiated recall is ongoing.


248 units


U.S. Nationwide

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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