Reported Dec 30, 2020 · Terminated
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for…
B Braun Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B Braun Medical, Inc. · 1601 Wallace Dr Ste 150 · Carrollton, TX · 75006-6690
Is this the product you have?
- APEX Compounding System Control Panel Module
- REF601238
- Product Code AX1000 - Product Usageintended for intravascular administration to a patient
- Lot codes and dates
- All APEX Compounding System with Software Version 1.0.5.57 or earlier
- Amount recalled
- 16 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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