APEX Compounding System Control Panel Module — Class II medical device recall Z-0718-2021
Terminated recall by B Braun Medical, Inc., reported 2020-12-30, distributed nationwide. There is the potential for the compounding system to not immediately interrupt compounding and alert user to t
| Recall number | Z-0718-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical, Inc., Carrollton, TX, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2023-03-14 |
| Distributed | Nationwide (US) |
| Quantity | 85 units |
| Model numbers | 601237 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0718-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.