Z-0717-2021Class II

APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 -

Name: Z-0717-2021 APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 -
Creator: B Braun Medical, Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2020-11-23 / Terminated / root cause: software

FDA source

B Braun Medical, Inc. began a recall of APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient on 2020-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0717-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Posted: 2020-12-23
Terminated: 2023-03-14
Recalling firm: B Braun Medical Inc
Product: APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Product code: NEP System/Device, Pharmacy Compounding
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.
Root cause tag: software
FDA root cause: Software change control
Action: On Nov. 23, 2020, the firm issued a "Urgent Medical Device Correction" letter to affected consignees via USPS mail. In addition to informing consignees about the recall device, the firm requested consignees take the following actions: 1. Review the URGENT MEDICAL DEVICE CORRECTION Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this voluntary Medical Device Correction and the affected product(s). 2. Ensure workflow(s) are in place to review air bubbles and scrap any final containers which exceed your facilitys guidelines until your APEX Compounding System has been upgraded to Software Version 1.0.5.58 or higher. " When compounding is complete, if bubbles were detected, APEX activates the Bubble Events button on the Compounding Complete screen allowing you to review the bubbles detected during compounding. " Until such time as your APEX software has been updated, BBMI recommends having qualified pharmacy personnel review this screen prior to removing the final container to ensure that the size of any air bubbles are within an allowable range per your facilitys guidelines. " Alternatively, your facility can have qualified personnel review each Compounding Activity Report generated by the device which also contains air bubble information. " Instructions for viewing the Bubble Events screen are provided in Attachment 02 of this Notice. Instructions for printing and reviewing the Compounding Activity Report are provided in Attachment 03 of this Notice. " Any final containers which exceed your facilitys allowable range should be scrapped. 3. Return the completed Acknowledgement Medical Device Correction form to BBMI by utilizing the enclosed self-addressed envelope or via scanned e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). It is important this form is
Quantity in commerce: 248 units
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.
Product codes and lots: All APEX Compounding System with Software Version 1.0.5.57 or earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0717-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0718-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0719-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)