| | Class 2 Device Recall BD Pyxis MedBank CUBIE Replenishment Station |  |
| 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-1550-2025 |
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| Recall Event ID |
96310 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | BD Pyxis MedBank CUBIE Replenishment Station
Product / Material ID
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01
BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01
BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 155156-01
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 155157-01
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P / 155151-01
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 155152-01
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 155153-01
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 155154-01
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 155155-01
BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 155146-01
BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 155147-01
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 155148-01
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 155149-01
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 155150-01
BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 169-114
BD PYXIS MEDBANK MINI CR-4HH-P / 169-115
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 169-82
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 169-83
BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 169-84
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 169-85
BD PYXIS MEDBANK TWR MN CR-14HH-P / 169-86
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 169-87
BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 169-88
BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 169-89
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 169-90
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 169-91
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 169-92
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /169-93
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 169-94
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 169-95
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 169-96
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 169-97
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 169-98
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 169-99
BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 138913-01
BD PYXIS MEDBANK MINI CR-4HH-P / 138911-01
BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P / 139001-01
BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P / 139002-01
BD PYXIS MEDBANK MN 200 CR-4HH-P / 139000-01
BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P / 139020-01
BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P / 139018-01
BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P / 139019-01
BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P / 139021-01
BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P / 139022-01
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 138973-01
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 138975-01
BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 139073-01
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 138976-01
BD PYXIS MEDBANK TWR MN CR-14HH-P / 138977-01
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 138951-01
BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 139072-01
BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 139085-01
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 138968-01
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 138964-01
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 138966-01
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /138967-01
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 138969-01
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 138965-01
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 138971-01
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 138972-01
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 138974-01
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 138970-01
BD Pyxis QFill Replenishment Station / 138904-01
KIT BD PYXIS QFILL REPLENISHMENT STATION / 155197-01
MEDBANK UPOS211 AIO WIN10 QFILL 1.5 / 155215-05
OPT,MEDBANK,HD,WIN10,QFILL,CR / 131944-04
The BD Pyxis" MedBank" CUBIE" Replenishment Station is an Automated Dispensing Cabinet (ADC) that is intended to be used by a qualified and authorized user to replenish medications and supplies to a BD Pyxis" MedBank" cabinet. |
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| Code Information |
Product / Material ID / GTIN
OPT,MEDBANK,HD,WIN10,QFILL,CR 131944-04 N/A
BD Pyxis QFill Replenishment Station 138904-01 N/A
BD PYXIS MEDBANK MINI CR-4HH-P 138911-01 N/A
BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138913-01 N/A
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 138951-01 N/A
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138964-01 N/A
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138965-01 N/A
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138966-01 N/A
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138967-01 N/A
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138968-01 N/A
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138969-01 N/A
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 138970-01 N/A
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138971-01 N/A
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138972-01 N/A
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138973-01 N/A
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138974-01 N/A
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 138975-01 N/A
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138976-01 N/A
BD PYXIS MEDBANK TWR MN CR-14HH-P 138977-01 N/A
BD PYXIS MEDBANK MN 200 CR-4HH-P 139000-01 N/A
BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139001-01 N/A
BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139002-01 N/A
BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139018-01 N/A
BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139019-01 N/A
BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139020-01 N/A
BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139021-01 N/A
BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 139022-01 N/A
BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139072-01 N/A
BD PYXIS MEDBANK TWR MN CR-12HH-1FH 139073-01 N/A
BD PYXIS MEDBANK TWR MN CR-2HH-6FM 139085-01 N/A
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 10885403504440
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 10885403503580
BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 10885403504457
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 10885403504464
BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 10885403504471
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 10885403504488
BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 10885403504754
BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 10885403504761
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 10885403504778
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 10885403504785
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 10885403504792
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 10885403504709
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 10885403504716
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 10885403504723
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 10885403504730
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 10885403504747
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 10885403504624
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 10885403504631
KIT BD PYXIS QFILL REPLENISHMENT STATION 155197-01 N/A
MEDBANK UPOS211 AIO WIN10 QFILL 1.5 155215-05 N/A
BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 10885403512544
BD PYXIS MEDBANK MINI CR-4HH-P 169-115 10885403512544
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 10885403512568
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 10885403512568
BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 10885403512568
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 10885403512568
BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 10885403512568
BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 10885403512568
BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 10885403512568
BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 10885403512568
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 10885403512568
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 10885403512568
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 10885403512568
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 10885403512568
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 10885403512568
BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 10885403512568
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 10885403512568
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 10885403512568
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 10885403512568
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 10885403512568
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| FEI Number |
2016493
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Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
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| For Additional Information Contact |
888-876-7128 |
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Manufacturer Reason
for Recall | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On 03/11/2025, firm sent via FedEx 2-day mail and email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them of 3 failure scenarios associated with:
-BD Pyxis MedBank CUBIE Replenishment (CR) Station
-BD Pyxis MedBank Mini
-BD Pyxis MedBank Tower
-BD Pyxis MedFlex
-BD Pyxis MedBank MedPass
Where failure of these systems could result in inaccuracies or discrepancies in inventory management of medications.
Customer are instructed to:
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.1
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.Please share this letter with any facilities within your network that you may have distributed affected devices to.
5.Please 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 the attached Response Form and return per the instructions noted on the form even if you do not you have any of the recalled products so that BD may acknowledge your receipt of this recall notification.
For questions or assistance:
email BDRC44@BD.com or Phone 1-866-930-9251 24 hour, 7 days a week |
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| Quantity in Commerce | 404 systems |
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| Distribution | U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV.
O.U.S.: None |
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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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