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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94699

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 02, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CareFusion 303, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2374-2024
Recall number
Z-2374-2024
Initiated
May 02, 2024
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
326

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
error that prevents the user from accessing the dispensing software
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
production environment, then this will will lead to an error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 information

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 pattern

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.