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Recall Observatory FDA recall evidence

Device product

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.

Z-1545-2025

March 11, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 96557
Status
Ongoing
Classification
Class II
Quantity
7357
Official record key
device-enforcement:Z-1545-2025

Official wording

Reason: Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

Code information: REF/UDI-DI(GTIN)/Software Version: 169-143/10885403512568/2.4; 169-145/10885403512568/2.4; 169-144/10885403512568/2.4; 169-142/10885403512568/2.4; 139088-01/1.2.3.23; 155288-01/10885403508721/2.4; 169-137/10885403512544/2.4; 155311-01/10885403510847/2.4; 169-151/10885403512544/1.2.3.23; 138921-01/2.4; 155159-01/10885403504655/2.4; 169-101/10885403512544/2.4; 139122-01/2.4; 155160-01/10885403504662/2.4; 169-102/10885403512544/2.4; 138912-01/2.4; 155161-01/10885403504679/2.4; 169-103/10885403512544/2.4; 138902-01/2.4; 169-104/10885403512544/2.4; 138903-01/2.4; 155163-01/10885403504686/2.4; 169-105/10885403512544/2.4; 138908-01/2.4; 169-106/10885403512544/2.4; 138906-01/2.4; 155165-01/10885403504693/2.4; 169-107/10885403512544/2.4; 169-152/10885403512544/1.2.3.23; 138907-01/2.4; 155166-01/10885403504570/2.4; 169-108/10885403512544/2.4; 139131-01/2.4; 155167-01/10885403504587/2.4; 169-109/10885403512544/2.4; 139091-01/2.4; 155168-01/10885403504594/2.4; 169-110/10885403512544/2.4; 138909-01/2.4; 155169-01/10885403504600/2.4; 169-111/10885403512544/2.4; 138910-01/2.4; 155310-01/10885403510830/2.4; 169-112/10885403512544/2.4; 169-150/10885403512544/1.2.3.23; 138915-01/2.4; 155171-01/10885403504617/2.4; 169-113/10885403512544/2.4; 138943-01/2.4; 155081-01/10885403503870/2.4; 169-23/10885403512568/2.4; 138955-01/2.4; 155082-01/10885403503887/2.4; 169-24/10885403512568/2.4; 138924-01/2.4; 155083-01/10885403503894/2.4; 169-25/10885403512568/2.4; 138960-01/2.4; 155084-01/10885403503900/2.4; 169-26/10885403512568/2.4; 138961-01/2.4; 155085-01/10885403503917/2.4; 169-27/10885403512568/2.4; 138926-01/2.4; 155086-01/10885403503726/2.4; 169-28/10885403512568/2.4; 138927-01/2.4; 155087-01/10885403503733/2.4; 169-29/10885403512568/2.4; 155293-01/10885403509926/2.4; 169-138/10885403512568/2.4; 155303-01/10885403510779/2.4; 139082-01/2.4; 155088-01/10885403503740/2.4; 169-30/10885403512568/2.4; 155305-01/10885403510793/2.4; 139056-01/2.4; 155089-01/10885403503757/2.4; 169-31/10885403512568/2.4; 155304-01/10885403510786/2.4; 139045-01/2.4; 155090-01/10885403503764/2.4; 169-32/10885403512568/2.4; 138932-01/2.4; 155091-01/10885403503771/2.4; 169-33/10885403512568/2.4; 139084-01/2.4; 155092-01/10885403503788/2.4; 169-34/10885403512568/2.4; 138963-01/2.4; 155093-01/10885403503795/2.4; 169-35/10885403512568/2.4; 155294-01/10885403509933/2.4; 169-139/10885403512568/2.4; 138938-01/2.4; 155094-01/10885403503801/2.4; 169-36/10885403512568/2.4; 139125-01/2.4; 155095-01/10885403503818/2.4; 169-37/10885403512568/2.4; 138919-01/2.4; 155096-01/10885403503696/2.4; 169-38/10885403512568/2.4; 139126-01/2.4; 155097-01/10885403504198/2.4; 169-39/10885403512568/2.4; 139127-01/2.4; 155098-01/10885403503702/2.4; 169-40/10885403512568/2.4; 139043-01/2.4; 155099-01/10885403504204/2.4; 169-41/10885403512568/2.4; 138933-01/2.4; 155100-01/10885403504211/2.4; 169-42/10885403512568/2.4; 155299-01/10885403510526/2.4; 169-140/10885403512568/1.2.3.23; 139142-01/2.4; 155101-01/10885403504228/2.4; 169-43/10885403512568/2.4; 155302-01/10885403510762/2.4; 138959-01/2.4; 155102-01/10885403504235/2.4; 169-44/10885403512568/2.4; 138954-01/2.4; 155103-01/10885403504242/2.4; 169-45/10885403512568/2.4; 138934-01/2.4; 155104-01/10885403504259/2.4; 169-46/10885403512568/2.4; 138950-01/2.4; 155105-01/10885403503719/2.4; 169-47/10885403512568/2.4; 138947-01/2.4; 155106-01/10885403504266/2.4; 169-48/10885403512568/2.4; 138945-01/2.4; 155107-01/10885403504273/2.4; 169-49/10885403512568/2.4; 138931-01/2.4; 155108-01/10885403504280/2.4; 169-50/10885403512568/2.4; 138929-01/2.4; 155109-01/10885403504327/2.4; 169-51/10885403512568/2.4; 138946-01/2.4; 155110-01/10885403504297/2.4; 169-52/10885403512568/2.4; 138940-01/2.4; 155111-01/10885403504303/2.4; 169-53/10885403512568/2.4; 138952-01/2.4; 155112-01/10885403504099/2.4; 169-54/10885403512568/2.4; 138917-01/2.4; 155113-01/10885403504105/2.4; 169-55/10885403512568/2.4; 138918-01/2.4; 155114-01/10885403504112/2.4; 169-56/10885403512568/2.4; 138941-01/2.4; 155115-01/10885403504129/2.4; 169-57/10885403512568/2.4; 138905-01/2.4; 155116-01/10885403504136/2.4; 169-58/10885403512568/2.4; 138916-01/2.4; 155117-01/10885403504143/2.4; 169-59/10885403512568/2.4; 139141-01/2.4; 155118-01/10885403504150/2.4; 169-60/10885403512568/2.4; 138914-01/2.4; 155119-01/10885403504334/2.4; 169-61/10885403512568/2.4; 139063-01/2.4; 155120-01/10885403504167/2.4; 169-62/10885403512568/2.4; 138953-01/2.4; 155121-01/10885403504174/2.4; 169-63/10885403512568/2.4; 138936-01/2.4; 155122-01/10885403504181/2.4; 169-64/10885403512568/2.4; 138962-01/2.4; 155123-01/10885403504082/2.4; 169-65/10885403512568/2.4; 138944-01/2.4; 155124-01/10885403504075/2.4; 169-66/10885403512568/2.4; 138957-01/2.4; 155125-01/10885403503658/2.4; 169-67/10885403512568/2.4; 138922-01/2.4; 155126-01/10885403503665/2.4; 169-68/10885403512568/2.4; 138930-01/2.4; 155127-01/10885403503672/2.4; 169-69/10885403512568/2.4; 139128-01/2.4; 155128-01/10885403503689/2.4; 169-70/10885403512568/2.4; 138958-01/2.4; 155129-01/10885403504341/2.4; 169-71/10885403512568/2.4; 138920-01/2.4; 155130-01/10885403504358/2.4; 169-72/10885403512568/2.4; 138937-01/2.4; 155131-01/10885403504365/2.4; 169-73/10885403512568/2.4; 139086-01/2.4; 155132-01/10885403504372/2.4; 169-74/10885403512568/2.4; 138942-01/2.4; 155133-01/10885403503542/2.4; 169-75/10885403512568/2.4; 138949-01/2.4; 155134-01/10885403503559/2.4; 169-76/10885403512568/2.4; 139062-01/2.4; 155135-01/10885403503566/2.4; 169-77/10885403512568/2.4; 138939-01/2.4; 155136-01/10885403503573/2.4; 169-78/10885403512568/2.4; 138948-01/2.4; 155137-01/10885403503597/2.4; 169-79/10885403512568/2.4; 138956-01/2.4; 155138-01/10885403503603/2.4; 169-80/10885403512568/2.4; 138923-01/2.4; 155139-01/10885403503610/2.4; 169-81/10885403512568/2.4; 139163-01/2.4. 1119-00/10885403512704/2.4; 1139-00/10885403512704/2.4. 139054-01/2.4; 139055-01/2.4; 139053-01/2.4; 139041-01/2.4; 139046-01/2.4; 139038-01/2.4; 139040-01/2.4; 139049-01/2.4; 139044-01/2.4; 139039-01/2.4; 139051-01/2.4; 139164-01/2.4; 139052-01/2.4; 139070-01/2.4; 139071-01/2.4; 139061-01/2.4; 139066-01/2.4; 139065-01/2.4; 139058-01/2.4; 139060-01/2.4; 139067-01/2.4; 139064-01/2.4; 139059-01/2.4; 139068-01/2.4; 139165-01/2.4; 139069-01/2.4. 1144-00/2.4; 1137-00/2.4; 1147-00/10885403517181/2.4 1145-00/10885403517167/2.4

Distribution pattern: US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL, KS, MI, IN, MN, MT, KY, MO, UT, NJ, OH, PA, ND, OR, NE, SD, NV, OK, GA, MA, IA, HI, ME, AZ, IL, SC, LA, WV, AL, ID, NM, DC, NH, VT, CT, MD, AR, WY.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software bug