| | Class 2 Device Recall BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass |  |
| Date Initiated by Firm | March 11, 2025 |
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| Date Posted | April 09, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1545-2025 |
|---|
| Recall Event ID |
96557 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| 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. |
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| 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
|
Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | On 3/11/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were mailed and emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, and other customers asking them to take the following actions:
1) Best practice is to verify the total dose being removed is accurate against the provider's order, and if available utilize barcode medication administration as an additional check to ensure the correct dose is retrieved prior to administration.
2) Customers can inventory the CUBIE pocket via a cycle count or blind count to correct the inventory when discrepancies occur. Customers can refer to the BD Pyxis MedBank Cabinet User Guide - 10000414987 Ver. 01, Version v2.4 for instructions. Refer to chapter six (6), page 103.
3)Customers should ensure backup procedures (which may include but are not limited to keys, emergency medication supplies, alternate devices in proximity, etc) are in place and staff have all been properly educated on them.
4) Share this letter with any facilities within your network that you may have distributed affected devices to.
5) Post this Recall Letter on or near affected products as a reminder of the recall and the steps/instructions that are needed to be followed.
6) Complete and return the Response Form via email to bdrc44@bd.com
Firm is in the process of contacting all customers to schedule an appropriate time for the software upgrade to MedBank software version 1.7.
If you require further assistance, contact the firm's technical support: 1-866-930-9251
Phone Hours: 24 hours, 7 days a week
Website: https://bdx.my.site.com/CC360/s/impactedproducts?rn=MMS-24-5163/MMS-25-5183/5184 |
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| Quantity in Commerce | 7357 |
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| Distribution | 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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