Recall Z-0718-2021— B Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B Braun Medical, Inc., initiated 2020-11-23, terminated 2023-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.. 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..
- Recalling firm
- B Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-23
- Terminated
- 2023-03-14
- Firm location
- Carrollton, TX, United States
Product description
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.