Recall – Software error can result in inaccurate drug compounds

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

PRODUCT

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

REASON

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.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

248 units

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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