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