B Braun recalls APEX Compounding System Control Panel Module (AX1000) with software version 1.0.5.57 or earlier. The system may not detect air bubbles exceeding 3% of the ordered volume, risking inaccurate drug compounding.
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 the APEX Compounding System Control Panel Module (product code AX1000) with software version 1.0.5.57 or earlier. This recall is because the system might not alert users to air bubbles larger than 3% of the ordered drug volume, which could lead to compounded drugs that don't meet accuracy requirements.
The control panel may fail to detect air bubbles exceeding 3% of the ordered drug volume during compounding. This could result in compounded drugs that don't meet the required accuracy for individual ingredients, potentially affecting patient safety.
Healthcare professionals using the APEX Compounding System with software version 1.0.5.57 or earlier for intravascular drug administration are most at risk. Patients receiving compounded drugs from this system could be affected if the drug accuracy is compromised.
Check for the product code AX1000 with software version 1.0.5.57 or earlier on the control panel module. The system is intended for intravascular drug administration to patients.
Verify the software version on the control panel module; if it is 1.0.5.57 or earlier, the product is affected.
The recall is for potential inaccuracies in compounded drugs due to air bubble detection issues, but it does not indicate immediate risk of serious injury.
Look for the product code AX1000 with software version 1.0.5.57 or earlier on the control panel module.
The recall does not specify a remedy, so contact B Braun Medical for further guidance.
We’ve drafted a message you can send B Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0718-2021 — B Braun B Braun Hello, I own a B Braun that is covered by recall Z-0718-2021 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.
