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BD Pyxis recallZ-1550-2025 · CareFusion 303, Inc. · initiated Mar 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected] or Phone 1-866-930-9251 24 hour, 7 days a week

Recall details

Recall number
Z-1550-2025
Status
Open, Classified
Initiated by the company
Mar 11, 2025
Posted by the FDA
Apr 9, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
404 systems
Product code
BRY
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

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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