# FDA recall Z-0717-2021

> **B Braun Medical, Inc.** · Class II · device recall initiated 2020-11-23.

## Product

APEX Compounding System Control Panel Module, REF: 601224, 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.

## Distribution

US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.

## Key facts

- **Recall number:** Z-0717-2021
- **Recalling firm:** B Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-23
- **Report date:** 2020-12-30
- **Termination date:** 2023-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carrollton, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2021

## Citation

> AI Analytics. FDA recall Z-0717-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0717-2021. Source: US FDA. Licensed CC0.

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