Class II — B Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient. |
| Quantity | 16 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. |
| Initiated | 2020-11-23 |
| Classified | 2020-12-23 |
| Terminated | 2023-03-14 |
| Recall number | Z-0719-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — B Braun Medical, Inc. (Z-0719-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86803/
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