medical Class II Updated 2020-12-30

B Braun Medical, Inc. recalls APEX Compounding System Control Panel Module, REF: 601237, P

Recalled Product

APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All APEX Compounding System with Software Version 1.0.5.57 or earlier
View official government recall

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