Z-0719-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 23, 2020
- Termination Date
- March 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
APEX Compounding System Control Panel Module, REF: 601238, 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.
Distribution Pattern
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