Class 2 Device Recall Apex Compounding System

• Date Initiated by Firm: November 23, 2020
• Create Date: December 23, 2020
• Recall Status: Terminated on March 14, 2023
• Recall Number: Z-0718-2021
• Recall Event ID: 86803
• Product Classification: System/device, pharmacy compounding - Product Code NEP
• Product: APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
• Code Information: All APEX Compounding System with Software Version 1.0.5.57 or earlier
• Recalling Firm/ Manufacturer: B Braun Medical, Inc.; 1601 Wallace Dr Ste 150; Carrollton TX 75006-6690
• For Additional Information Contact: B. Braun Customer Support; 800-227-2862
• Manufacturer 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.
• FDA Determined 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 BBMUS_Carrollton_QualitySystemManagement@bbraunusa.com 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: 85 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.