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 drug 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 (product code AX1000) that could produce compounded drugs with inaccurate ingredient measurements due to air bubble issues. This risk affects medical use where precise drug dosing is critical.
The control panel may fail to detect air bubbles larger than 3% of the ordered drug volume. This could cause compounded medications to have incorrect ingredient concentrations, potentially leading to unsafe drug doses for patients.
Healthcare facilities using the APEX Compounding System with software version 1.0.5.57 or earlier are most at risk. Patients receiving compounded medications from these systems could be affected if the system produces inaccurate drug doses.
Check if your APEX Compounding System has software version 1.0.5.57 or earlier. The product code is AX1000 with reference number 601224.
Verify your APEX Compounding System software version. If it is 1.0.5.57 or earlier, it is affected.
The recall addresses a potential risk of inaccurate drug dosing due to air bubbles, but it does not indicate immediate danger to users.
The recall does not specify a remedy, so check with B Braun for guidance if you have the affected product.
Look for software version 1.0.5.57 or earlier on your APEX Compounding System with product code AX1000 and reference number 601224.
We’ve drafted a message you can send B Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0717-2021 — B Braun B Braun Hello, I own a B Braun that is covered by recall Z-0717-2021 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.
