BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operatin

FDA device recall Z-1785-2022 · posted 2022-09-23 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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 taken

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: MedBanksupport@BD.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BRY

Quantity affected

686 cabinets

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,

Date initiated

2022-05-24

Date posted

2022-09-23

Location

San Diego, CA