FDA Recall Open, Classified

BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intended to securely store and dispense medications to health care providers in a clinical setting.

Recall: Z-1785-2022 · Initiated May 24, 2022

Recall

Recall Number
Z-1785-2022
Event Number
90600
Firm
CareFusion 303, Inc.
FEI Number
2016493
Product Code
BRY
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
May 24, 2022
Posted
September 23, 2022
Address
10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intended to securely store and dispense medications to health care providers in a clinical setting.

Reason

The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop opening in the MedBank Application) leading to delay in access to medications or supplies needed in residential or procedural care facilities.

Action

On 05/24/2022, BD engineers remotely performed the roll-back of the incompatible .dll files on the affected device. The affected pharmacies were verbally notified prior to and after the fix being implemented. Beginning in September 2022, BD will send an "Urgent Medical Device Product Correction" letter to customers informing them that they are performing a product correction for legacy MedBank Cabinets with Matrix drawers, due to a known issue when installing BD Pyxis MedBank Cabinets software version 2.1.2.9. Impacted Legacy MedBank Cabinets with Matrix drawers include: " CUBEX MedFlex operating with Windows 7 " MedBank 200 Main operating with Windows 7 " MedBank 500 Main operating with Windows 7 Actions to be taken by Pharmacy: 1. Provide a copy of this customer letter to all facilities within their distribution network, that have any product listed in the Affected Products section above, on BD s behalf. Actions to be taken by the Customer: 1. Post this Customer Notification on all affected devices until additional software updates have been released. 2. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that they understand the information provided in this letter. 3. If customers experience loss in drawer functionality, please reach out to BD Technical Support/Product Complaints. Actions to be taken by BD: 1. BD has reverted all .dll files to the previous version on affected cabinets. 2. Additional software updates to legacy MedBank Cabinets with Matrix drawers will be available in the future. BD will contact customer to schedule a convenient time to update the software on their affected units. BD will remotely perform all necessary software updates at no charge. Questions - Technical Question - Phone: 1-866-930-9251 hours: 24 hours, 7 days a week Email: [email protected]

Distribution

U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME,. MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Quantity

686 cabinets