BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD

FDA device recall Z-1550-2025 · posted 2025-04-09 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

Action taken

On 03/11/2025, firm sent via FedEx 2-day mail and email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them of 3 failure scenarios associated with: -BD Pyxis MedBank CUBIE Replenishment (CR) Station -BD Pyxis MedBank Mini -BD Pyxis MedBank Tower -BD Pyxis MedFlex -BD Pyxis MedBank MedPass Where failure of these systems could result in inaccuracies or discrepancies in inventory management of medications. Customer are instructed to: 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.1 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.Please share this letter with any facilities within your network that you may have distributed affected devices to. 5.Please 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 the attached Response Form and return per the instructions noted on the form even if you do not you have any of the recalled products so that BD may acknowledge your receipt of this recall notification. For questions or assistance: email BDRC44@BD.com or Phone 1-866-930-9251 24 hour, 7 days a week

Root cause

Device Design

Status

Open, Classified

Product code

BRY

Quantity affected

404 systems

Distribution

U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV. O.U.S.: None

Date initiated

2025-03-11

Date posted

2025-04-09

Location

San Diego, CA