FDA Device recall Z-0719-2021
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration t…
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration t… by B Braun Medical, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0719-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-23 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
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.
Identifiers
| code_info | All APEX Compounding System with Software Version 1.0.5.57 or earlier |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0719-2021%22
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