Z-1545-2025 Class II Ongoing
FDA device recall Z-1545-2025 was initiated by CareFusion 303, Inc. on March 11, 2025 and is designated Class II. Reason for recall: 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 al… The recall status is ongoing. Affected quantity: 7357.
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- March 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7357
Product Description
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.
Reason for Recall
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.
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.
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; 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