FDAFDA · Food and drugs·Recall number Z-0718-2021
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Published December 30, 2020 · Recall initiated: November 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical, Inc.
- Distributor
- 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.
- Lot
- All APEX Compounding System with Software Version 1.0.5.57 or earlier
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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