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

62304 Software Training Course – February 23-25, 2021

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

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15148 Springview St
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Partners located in the US (CA, FL, MA, MN) and Italy.