FDAFDA · Food and drugs·Recall number Z-2374-2024
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
Published July 24, 2024 · Recall initiated: May 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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