BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    Recall: Z-2374-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2374-2024
    Event ID
    94699
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    July 24, 2024
    Initiation Date
    May 2, 2024
    Classification Date
    July 17, 2024
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    Reason

    If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

    Code Info

    REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745, 16220738, 16446299, 16446303, 16446302, 16247443, 16247440, 15962990, 16417275, 16446297, 16446296, 16242783, 16234266, 15425093, 16446295, 16446291, 16242784, 16417277, 15644176, 14019332, 16212329, 16221517, 16395857, 16059358, 16254191, 15319466, 15154945, 15153602, 16215325, 15154942, 14959051, 16395855, 16395853, 16215313, 16361893, 14826969, 14826972, 14826971, 14826973, 14232856, 16241342, 13877154, 15148881, 15148860, 15148880, 15148882, 15854601, 15148883, 15148865, 15148885, 15160417, 16212961, 15854595, 15148859, 15148862, 15148861, 15148863, 15148866, 15148868, 15854596, 15854600, 15148870, 15854597, 15854598, 15854599, 15148873, 15148864, 15148867, 15148884,15148878, 15148879, 16324054, 16223557, 15136666, 13841400, 14138516, 15519749, 16446315, 16141586, 16416617, 16416618, 16416622, 16416619, 16416621, 16416623, 16416616, 16416615, 13781497, 14557551, 16212312, 15500549, 14700155, 16212346, 16214431, 16214432, 16214430, 16214429, 16212344, 16247441, 16247444, 16320157, 16335215, 16204472, 15154938, 14813899, 14697245, 15642731, 16209866, 15135154, 16214435, 16446294, 16227849, 16446311, 16010961, 16375509, 15303370, 16415510, 14668921, 16239128, 16346806, 16242800, 16204479, 16352591, 16324052, 16222213, 16212322, 16271477, 15015227, 16214427, 16373774, 15978927, 16358533, 16215391, 16446313, 16446308, 16247439, 16247445, 16247442, 16347745, 16347746, 14157588, 16271458, 16346807, 15196235, 16322403, 16352593, 14728645, 16212338, 15519703, 16217225, 14806556, 16352598, 16352590, 16352595, 16352596, 15263493, 16216425, 16416639, 16416102, 16416104, 16416632, 16416108, 16416637, 16416110, 16416111, 16416106, 16416638, 14987500, 16234192, 16405456, 16405459, 15136661, 16242578, 16271457, 15911127, 15954728, 16271463, 16271465, 14966741, 16214437, 16324055, 16225327, 16407028, 14613489, 15997584, 14442210, 16357615, 16357616, 16307328, 13839287, 13839299, 15136665, 15045814, 16054085, 15642724, 16244068, 16346335, 16283945, 16231509, 16277495, 16240201, 16211337, 16291566, 16212335, 15933030, 16242781, 16346808, 15135153, 16204480, 16271460, 16212330, 16324056, 16215395, 16214434, 15454500, 16173369, 16423187, 15895362, 16242797, 16204482, 16274624, 16223058, 16223059, 16274625, 15540317, 16223060, 16274626, 16257759, 16352588, 16446301, 12345678, 16271461, 16352594, 16212342, 16120462, 16235542, 16242799, 16212336, 16468210, 16195795, 16211170, 15570657, 16223556, 16412617, 16412618, 16412615, 16412616, 16321316, 16022041, 16242801, 16267770, 15136667, 15136668, 16174009, 14956271, 15236068, 15236067, 16218170, 16061265, 14572826, 16128483, 16128482, 16143915, 15398129, 15449307, 16174023, 16174021, 16143913, 16174036, 16174008, 16174019, 16174020, 15449302, 15691588, 15449303, 16227720, 16446290, 16242780, 16242802, 16405462, 16116814, 16212339, 16008937, 16215393, 16215389, 16215398, 16223558, 15147150, 16342242, 16253003, 16253008, 15495195, 16149377, 16094701, 15560137, 16296089, 16296090, 16296091, 16296092, 13347728, 14826153, 16417216, 16417243, 16417242, 16324044, 16415642, 16419185, 16415641, 16415639, 16415640, 16242803, 16242804, 16212319, 15136664, 16262416, 15136663, 16317160, 16212343, 15136670

    Distribution

    Worldwide - US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC and the countries of TW, CA.

    Quantity

    326