Class 2 Device Recall BD Pyxis MedBank Cabinet Software v2.1.2.9

• Date Initiated by Firm: May 24, 2022
• Date Posted: September 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1785-2022
• Recall Event ID: 90600
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: 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.
• Code Information: Software Version - v2.1.2.9 UDI Code: N/A Cabinet System Serial Numbers containing the affected software: 14473379 15268856 14728142 15080054 14891492 15216161 13819501 14443828 14443829 14443838 14461825 14461827 14461829 14461830 14461836 14461838 14461840 14461842 14461843 14461845 14461848 14473356 14473359 14473371 14473376 14473377 14491507 14491510 14491511 14491513 14491514 14491516 14491518 14491519 14491523 14491524 14491526 14491529 14491533 14491534 14491535 14491536 14491537 14509122 14509123 14509124 14509126 14509128 14509130 14509136 14509137 14509138 14509139 14509141 14531591 14532282 14532284 14532285 14532286 14532287 14532290 14532294 14532295 14532298 14532299 14532300 14532301 14532302 14568029 14568034 14568035 14568036 14568037 14568038 14568041 14568042 14568045 14568046 14568050 14568054 14603154 14607364 14607368 14607369 14649246 14699416 14532304 14568027 14461834 14491520 14491522 14532288 14532292 14532305 14491512 14532297 14443834 14532293 14532291 14607366 14443839 14443843 14443844 14460707 14603175 14607367 14461824 14443836 14509115 14509119 14549534 15279454 14699033 14730460 14420208 14730461 14549537 14730464 14473369 14699031 15125784 15317097 14723851 15274579 14442685 14568030 14568031 15633002 14730471 13770291 15590120 14478424 14874166 13947037 15361553 14509135 15071140 14138680 15537380 15615141 14728129 15788870 15286943 14478435 14491530 14715885 15429584 15337472 14721968 15564896 15564893 15564894 15564895 15513825 14624517 14861727 14861748 14961881 14961882 14961883 14961884 15830892 13945496 13945495 14697343 15581965 15774188 15366948 14813913 15089507 14947859 14403527 14229977 15317101 14175169 15581964 14649237 14228154 14728127 14159916 14406629 14429784 14699405 14607360 14443841 14443842 14586208 14649230 14649232 14403531 15188738 15575589 15267549 15700819 14509113 14478428 14478431 14874162 15294475 14540101 14304064 15366950 14443824 15267544 14427167 13843251 14813912 14709254 15229116 14951360 15223571 15361558 15019691 15102966 14730447 14874163 14649240 14419507 14419508 15557264 14568057 14568064 13875126 14304066 14603146 14788043 14443831 14509125 14861747 14603168 14657501 14648248 14947856 14414504 15509359 13965052 14308767 14279544 14603172 13853916 14649239 15090717 14509131 14721964 15650666 15267500 14730465 14737828 14914161 14937418 15192525 14803084 15276090 15206267 15206269 15210095 15201878 15210090 15210104 13948724 15279442 15279444 15210091 15210094 15201877 15279443 13883357 13884848 15206270 15210088 15613096 15276088 14723853 15318395 15098244 14128591 15312344 14419509 14603174 14972153 15317120 14947857 14473373 14672320 14730458 14730470 14461826 14473374 15322321 15229109 15057618 15267502 14730462 15303223 15584199 14730456 14721965 14697341 14874159 14374965 14279552 14304065 14443830 14156545 14961873 15088028 14491527 14730443 14607365 14478427 14392749 14535392 14568051 14723242 15080055 15302367 15679243 14509114 14603139 14603142 14603143 14737822 15834992 14721967 14509121 15736824 15557611 15096795 14874161 14603173 14728140 14788047 14861753 14861745 15679254 14473366 13909811 14133113 14491517 14568028 14214950 14279557 14635122 15748543 14478433 14603163 14603166 15546742 15587220 14788045 15229119 15679237 14874167 14540879 15788868 15331136 14478434 14737825 13802400 15063109 14697342 14861756 14947855 15312346 14649245 14649249 14657505 14657506 14657508 14442686 15299618 15299619 15299620 15299621 15299622 14671989 14461846 14473380 15229115 14270255 14723855 14699034 14461839 14963125 15305249 14603177 14473358 14473375 14509133 15095961 14579394 15089508 15125779 14442800 15356965 14478425 14304062 15027469 15279450 15242599 15779891 15554707 14721966 15376276 14788046 14867006 15109587 15308357 15298295 15303224 14603141 14258664 15102967 15492649 15356973 14461828 15652138 14461835 14491525 15276086 14730452 15318393 15652147 15748544 14874165 14697340 14723867 14568048 14788044 15063111 14721962 14325479 15000454 15463095 14750082 14723845 15416741 14630724 14603144 14568032 14202339 15366949 14961880 14730448 14568061 15267501 15090718 14461837 15095962 15095960 15095963 15098243 15229118 15312343 15376146 15000254 15230957 15305090 15290668 15299942 15305089 14486821 15322152 15190476 14518086 15315573 15356968 15279452 15315572 15305242 14473285 15308353 15223562 15298296 15355354 15298294 15290669 15303222 15095959 15299938 14472073 14333231 14416475 14672318 14085448 14183625 14112707 14095393 14196851 14112706 15473692 15679245 15679263 15210089 14711353 14730451 14723866 15736832 14750090 15564897 14473362 15483513 15475980 15274578 14737824 14737827 15318399 14478432 14874160 14737829 14737830 14138682 15590119 14925753 15521199 14461844 14723857 14473372 14649250 15322322 15322320 15322324 15322323 15322317 15322325 15322326 15322319 15236627 14942508 15562706 14420213 14549542 14254816 14420211 14951344 14549535 14883876 14951354 14254815 14254812 14787919 15661681 14306555 14473357 14265655 15492248 15254778 15254772 15254774 15254775 15254776 15736823 14045577 14728138 15042014 14721963 14420222 14951377 14532289 14730450 14649227 13909812 15513831 15513833 15509361 15396726 15474551 15519700 15519704 15473693 15498908 15041225 14101916 15622613 15513826 13853918 15470035 13826187 14740989 15803799 14603179 14730441 14788048 15467518 15622635 14961875 15928168 15024804 14603151 14603165 14649235 15080053 14603147 14649229 14603169 14603170 14649247 15115950 15115955 14958134 15463216 15318400 15115957 15463220 14888639 15115956 15115959 15115960 14890183 15517161 15268835 15216160 15788872 14603145 14737826 15588927 15257622 15109527 15647364 14730449 15583141 13909807 14478430 15279458 15366947 14603167 14083989 14961877 14730442 14730444 14730446 14473368 14750088 15340245 15133219 15133220 14568043 14607361 14443849 15393558 15290673 15268831 15315526 14750085 14861746 14867007 14947858 14914167 14473361 14961874 14406871 15393520 15675069 14603171 14461831 14535391 14723864 14874168 15274576 15389013 14603152 14603181 14478429 15000459 14649226 14607370 14723850 15027467 14699403 15460707 15509364 14728143 15638496 14649202 15057619 14473365 14473370 14473360 14473367 14540113 13873024 15182585 15000252 14461841 14750086 13877713
• FEI Number: 2016493
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: 888-876-7128
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• 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: MedBanksupport@BD.com
• Quantity in Commerce: 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, TX, UT, VA, WA, WI, WV, and WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.