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
This recall is currently active, issued July 17, 2024. It was issued by Carefusion 303, Inc..
- Company
- Carefusion 303, Inc.
- Recall Initiated
- May 2, 2024
- Posted
- July 17, 2024
- Recall Number
- Z-2374-2024
- Quantity
- 326
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / 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
Root Cause
Software change control
Action Taken
On 6/6/24, correction notices were distributed to customers who were informed that their devices had been remediated. That they had been contacted by phone in May 2024 to schedule device remediation. The firm re-configured the component manager from "installed mode" to "disabled mode" and checked if the Microsoft patch was present on each device. If the patch was identified on a device, it was removed. All devices were then configured to "managed mode" and rebooted to enable the system appropriately. Customers are asked to complete and return the response form to Email BDRC15@bd.com For safety information about the system not covered in this document, call the firm's Technical Support Center at 1-800-727-6102, Phone hours: 24 hours, 7 days a week. Additional contacts include: 1) Regional Complaint Center, 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com 2) Post Market Quality Field Action Operations, BDRC15@bd.com