APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: i...
FDA Recall #Z-0718-2021 — Class II — November 23, 2020
Product Description
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Reason for Recall
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
B Braun Medical, Inc. — Carrollton, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
85 units
Distribution
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.
Code Information
All APEX Compounding System with Software Version 1.0.5.57 or earlier
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.