ClearanceBrief
Recall Z-1785-2022 ยท BRY Cabinet, Table And Tray, Anesthesia

CareFusion 303, Inc.

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.

DateSep 23, 2022 (initiated May 24, 2022)
StatusOpen, Classified
ReasonThe 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.
Root causeUnder Investigation by firm
ActionOn 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 ope
Quantity686 cabinets
DistributionU.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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.