B Braun recalls APEX Compounding System Control Panel Module (AX1000) with software version 1.0.5.57 or earlier due to potential air bubble errors in compounded drugs. Affected units may produce inaccurate medication doses.
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.
B Braun is recalling APEX Compounding System Control Panel Modules with software version 1.0.5.57 or earlier. The recall is because the system might not detect air bubbles larger than 3% of the drug volume, which could lead to inaccurate medication doses.
The control panel might fail to alert users when air bubbles exceed 3% of the ordered drug volume. This could cause compounded medications to be inaccurate, potentially leading to incorrect dosages for patients.
Healthcare professionals using the APEX Compounding System for intravenous drug preparation are most at risk. Patients receiving compounded medications from affected systems could receive incorrect dosages.
Check for the product code AX1000 with reference number 601238. Affected units have software version 1.0.5.57 or earlier. The system is used for intravenous drug preparation.
Verify the software version on the control panel. If it is 1.0.5.57 or earlier, the unit is affected.
The affected model is the APEX Compounding System Control Panel Module with product code AX1000 and reference number 601238.
The recall addresses a potential risk of inaccurate medication dosing due to undetected air bubbles, which could lead to incorrect drug concentrations for patients.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send B Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0719-2021 — B Braun B Braun Hello, I own a B Braun that is covered by recall Z-0719-2021 from B Braun. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
