Recall Z-0718-2021 ยท NEP System/Device, Pharmacy Compounding
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
| Date | Nov 23, 2020 |
| Status | Terminated |
| 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. |
| 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 guide |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.