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BD Pyxis recallZ-1552-2025 · CareFusion 303, Inc. · initiated Oct 5, 2023

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

If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.

FDA root cause category: Software design

What the company is doing

05OCT2023, Customer Release Notes were sent to customers informing them of system release v1.3.4. On 2/18/2025, correction notices were mailed and emailed to Customers, Directors of Pharmacy, and Facility Medication Management Administrators who were informed the following: 1) Customers with system administrator privileges can uncheck the option for the "Clear All" button in the BD Pyxis MedBank Facility Software, which will disable the feature and prevent the button from displaying on the patient profile selection screen. 2) Best practice is to verify the item being removed is accurate against the provider s order, and if available utilize barcode medication administration as an additional check to ensure the correct medication is retrieved prior to administration.1 3) Share and disseminate this notice within your facility network to ensure they are aware of the field action. 4) Complete and return the Customer Response Form via email to [email protected] BD Pyxis MedBank Facility Software version 2.5.1.4 within MedBank system release v1.7 is currently available and will address this issue. BD will contact impacted customers to schedule a time for software upgrade. If you have questions contact the firm's Technical Support at 1-866-930-9251 Phone Hours: 24 hours, 7 days a week.

Recall details

Recall number
Z-1552-2025
Status
Open, Classified
Initiated by the company
Oct 5, 2023
Posted by the FDA
Apr 11, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
2679
Product code
BRY
Distribution
US Nationwide distribution in the states of KS, TX, CA, PA, NJ, FL, IN, AZ, IL, MA, NY, KY, UT, MD, WA, OH, AL.

Product description

MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

BD Pyxis MedBank Receiving Cabinet Software Software versions: 2.1.2.11, 2.2.1.8, 2.31.8, 2.3.2.1, 2.4.2.26 REF/UDI-DI: 1119-00/10885403512704; 1137-00; 1139-00/10885403512704; 1145-00/10885403517167; 1147-00/10885403517181; 139090-01; 169-100/10885403512568; 169-101/10885403512544; 169-102/10885403512544; 169-103/10885403512544; 169-104/10885403512544; 169-105/10885403512544; 169-106/10885403512544; 169-107/10885403512544; 169-108/10885403512544; 169-109/10885403512544; 169-110/10885403512544; 169-111/10885403512544; 169-112/10885403512544; 169-113/10885403512544; 169-132/10885403512568; 169-137/10885403512544; 169-138/10885403512568; 169-139/10885403512568; 169-153/10885403512568; 169-155/10885403512568; 169-156/10885403512568; 169-159/10885403512544; 169-160/10885403512544; 169-161/10885403512544; 169-162/10885403512544; 169-23/10885403512568; 169-24/10885403512568; 169-25/10885403512568; 169-26/10885403512568; 169-27/10885403512568; 169-28/10885403512568; 169-29/10885403512568; 169-30/10885403512568; 169-31/10885403512568; 169-32/10885403512568; 169-33/10885403512568; 169-34/10885403512568; 169-35/10885403512568; 169-36/10885403512568; 169-37/10885403512568; 169-38/10885403512568; 169-39/10885403512568; 169-40/10885403512568; 169-41/10885403512568; 169-42/10885403512568; 169-43/10885403512568; 169-44/10885403512568; 169-45/10885403512568; 169-46/10885403512568; 169-47/10885403512568; 169-48/10885403512568; 169-49/10885403512568; 169-50/10885403512568; 169-51/10885403512568; 169-52/10885403512568; 169-53/10885403512568; 169-54/10885403512568; 169-55/10885403512568; 169-56/10885403512568; 169-57/10885403512568; 169-58/10885403512568; 169-59/10885403512568; 169-60/10885403512568; 169-61/10885403512568; 169-62/10885403512568; 169-63/10885403512568; 169-64/10885403512568; 169-65/10885403512568; 169-66/10885403512568; 169-67/10885403512568; 169-68/10885403512568; 169-69/10885403512568; 169-70/10885403512568; 169-71/10885403512568; 169-72/10885403512568; 169-73/10885403512568; 169-74/10885403512568; 169-75/10885403512568; 169-76/10885403512568; 169-77/10885403512568; 169-78/10885403512568; 169-79/10885403512568; 169-80/10885403512568; 169-81/10885403512568; 139089-01

Devices named in this recall

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

Product lines

Sources and updates

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