Recall StatusOpen, Classified
Date Initiated2025-03-11
Product Quantity7357
Reason for Recall
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
Firm Action
On 3/11/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were mailed and emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, and other customers asking them to take the following actions:
1) Best practice is to verify the total dose being removed is accurate against the provider's order, and if available utilize barcode medication administration as an additional check to ensure the correct dose is retrieved prior to administration.
2) Customers can inventory the CUBIE pocket via a cycle count or blind count to correct the inventory when discrepancies occur. Customers can refer to the BD Pyxis MedBank Cabinet User Guide - 10000414987 Ver. 01, Version v2.4 for instructions. Refer to chapter six (6), page 103.
3)Customers should ensure backup procedures (which may include but are not limited to keys, emergency medication supplies, alternate devices in proximity, etc) are in place and staff have all been properly educated on them.
4) Share this letter with any facilities within your network that you may have distributed affected devices to.
5) Post this Recall Letter on or near affected products as a reminder of the recall and the steps/instructions that are needed to be followed.
6) Complete and return the Response Form via email to
[email protected]
Firm is in the process of contacting all customers to schedule an appropriate time for the software upgrade to MedBank software version 1.7.
If you require further assistance, contact the firm's technical support: 1-866-930-9251
Phone Hours: 24 hours, 7 days a week
Website: https://bdx.my.site.com/CC360/s/impactedproducts?rn=MMS-24-5163/MMS-25-5183/5184
Root Cause
Software design
Distribution Pattern
US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL, KS, MI, IN, MN, MT, KY, MO, UT, NJ, OH, PA, ND, OR, NE, SD, NV, OK, GA, MA, IA, HI, ME, AZ, IL, SC, LA, WV, AL, ID, NM, DC, NH, VT, CT, MD, AR, WY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.