Class 2 Device Recall BD Pyxis CII Safe ES

• Date Initiated by Firm: November 14, 2024
• Date Posted: December 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0672-2025
• Recall Event ID: 95643
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD Pyxis CII Safe ES, REF: 1116-00
• Code Information: All software versions. REF/UDI-DI: 1116-00/10885403512605/ 15938609 15938608 15960426 15977244 15977243 15997587 15997584 15997586 16001276 16004167 16004170 16004168 16006959 16016028 16018286 16018285 16027068 16034363 16038606 16038608 16042040 16043100 16051041 16052300 16056892 16081629 16089006 16107354 16121844 16124176 16124177 16124175 16124174 16124178 16142019 16142717 16147368 16150604 16150317 16154380 16154381 16179910 16185906 16186402 16186403 16188916 16188917 16189876 16191858 16191855 16192478 16192476 16198735 16205805 16205708 16210899 16211121 16211303 16211474 16216310 16216322 16216171 16216317 16216324 16216170 16217014 16217009 16217010 16217006 16222804 16229923 16234971 16234972 16234970 16234973 16234969 16235009 16236311 16238237 16238264 16239968 16247326 16253283 16262739 16267647 16273818 16273822 16277384 16280705 16282121 16282137 16282082 16283296 16287656 16291326 16292340 16294019 16295348 16295346 16297236 16297224 16299107 16300479 16309949 16315507 16317206 16317204 16317205 16317207 16319700 16319670 16322458 16322446 16323719 16327551 16335942 16337405 16338265 16338264 16344600 16344608 16349184 16349205 16354606 16380050 16381506 16381558 16411952 16411951 16412194 16413752 16413747 16415153 16415200 16415590 16416557 16416531 16418522 16418188 16418187 16418507 16423221 16425773 16426437 16433986 16444194 16445004 16444237 16445017 16460539 16461440 16460710 16460551 16468172 16468090 16468208 16468173 16468174 16469932 16474654 16479163 16484107 16487985 16490699 16507895 16507875 16529195 16538278 16550545 16554103 16554102 16554100 16554079 16582605 16585680 16585665 16585669 16585576 16585655 16595099 16595093 16601179 16627555 16626472 16627561 16626460 16630815 16641357 16664753 16672435 16685055 16685063 16706784 16706834 16712895 16719658 16719611 16719695 16755235 16755194 16764093 16767178 16769446 16773194 16785716 16785719 16790736 16808348 16808370 16808330 16811697 16826563 16832646 16832644 16832647 16843563 16881356 16907911
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
• FDA Determined Cause: Software design
• Action: On 11/14/24, correction notices were mailed/emailed to customers: Devices can continue to be used in accordance with the following: Best practice is for providers (e.g., nurses) to verify the medication being removed is accurate against the hospital patient record (source of truth) prior to administration1. o Labeling includes the following warning: Always utilize the BD Pyxis ES System patient/order information in conjunction with the medical record when making clinical decisions. Making clinical decisions solely from System information may result in errors in care resulting in serious injury or death. " To further aid that verification step, it has been estimated that BCMA (Barcode Medication Administration) can reduce medication administration errors. Similarly, "Scan on Remove" functionality can be enabled within the MedStation to help capture an erroneously dispensed medication. " Safe storage and labeling for neuromuscular blocking (NMB) agents - Institute for Safe Medication Practices (ISMP) recommends to segregate, sequester, and differentiate NMBs from other medications. This can help identify a high-risk medication is being removed in error. " If a different medication is dispensed, the error may be caught during the check process prior to leaving the pharmacy. If error is not caught, pharmacy technician will still refill/load the medication dispensed properly at the device. " ES server includes notifications for those medication pockets that are empty within the System to trigger pharmacy to refill. Complete and return response form to BDRC1@bd.com For further assistance, contact firm: Technical Support - 1-800-727-6102, 24 hours, 7 days a week; Regional Complaint Center, 1-844-823-5433, Mon-Fri 8:00am-5:00pm CT, productcomplaints@bd.com; Post Market Quality Operations, Fax: 1-410-316-4258, Email: BDRC1@bd.com On 2/6/2025, updated correction notices were sent notifying customers that the firmware update was available.
• Quantity in Commerce: 218
• Distribution: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
• 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.