| | Class 2 Device Recall BD Pyxis MedBank and BD Pyxis MedFlex |  |
| Date Initiated by Firm | October 05, 2023 |
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| Date Posted | April 11, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1552-2025 |
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| Recall Event ID |
96029 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | 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 |
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| Code Information |
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
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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 | 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. |
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FDA Determined
Cause 2 | Software design |
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| Action | 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 BDRC23@bd.com
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. |
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| Quantity in Commerce | 2679 |
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| 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.
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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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