| | 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 18, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1639-2025 |
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| Recall Event ID |
96564 |
| Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
| Product | BD PYXIS MEDBANK (Name, REF):
MEDPASS MODULE, 139088-01;
MINI 1FH-1FM, 169-137;
MINI 1HH-1FH-1HM, 169-101;
MINI 1HH-1HM-1FM, 169-102;
MINI 2FH, 138902-01;
MINI 2FH, 169-104;
MINI 2FM, 169-105;
MINI 2HH-1FH, 169-106;
MINI 2HH-1FH, 138908-01;
MINI 2HH-1FM, 169-107;
MINI 2HH-1FM, 138906-01;
MINI 3HH-1FG, 169-110;
MINI 3HH-1FG, 139091-01;
MINI 3HH-1HM, 169-111;
MINI 4HH, 138910-01;
MINI 4HH, 169-112;
MINI 4HM, 169-113;
MINI 4HM, 138915-01;
TWR MN 10HH-1FH-1FM, 169-23;
TWR MN 10HH-2FH, 169-24;
TWR MN 10HH-2FH, 138955-01;
TWR MN 10HH-2FM, 169-25;
TWR MN 10HH-2FM, 138924-01;
TWR MN 12HH-1FF, 169-26;
TWR MN 12HH-1FF, 138960-01;
TWR MN 12HH-1FH, 169-27;
TWR MN 12HH-1FH, 138961-01;
TWR MN 12HH-1FM, 169-28;
TWR MN 12HH-1FM, 138926-01;
TWR MN 14HH, 138927-01;
TWR MN 14HH, 169-29;
TWR MN 1HH-1HM-2FM-4FF, 169-30;
TWR MN 2FH-2HM-4FM, 169-31;
TWR MN 2HH-10HM-1FM, 169-32;
TWR MN 2HH-1FH-5FM, 169-33;
TWR MN 2HH-2FH-4FM, 169-34;
TWR MN 2HH-4FH-2FM, 169-139;
TWR MN 2HH-4HM-4FM, 139125-01;
TWR MN 2HH-6FM, 169-38;
TWR MN 2HH-6FM, 138919-01;
TWR MN 2HH-6HM-3FM, 169-39;
TWR MN 2HH-8HM-2FM, 169-40;
TWR MN 2HM-6FM, 169-41;
TWR MN 3FH-4FM, 169-42;
TWR MN 3FH-4FM, 138933-01;
TWR MN 3FH-8HH MEDPASS, 169-140;
TWR MN 3HH-7HM-2FM, 169-43;
TWR MN 4HH-10HM, 169-44;
TWR MN 4HH-10HM, 138959-01;
TWR MN 4HH-1FH-2HM-3FM, 169-45;
TWR MN 4HH-1FH-4FM, 169-46;
TWR MN 4HH-1FH-4HM-2FM, 169-47;
TWR MN 4HH-2FH-2HM-2FM, 169-49;
TWR MN 4HH-2FH-3FM, 169-50;
TWR MN 4HH-2FH-3FM, 138931-01;
TWR MN 4HH-3FH-2FM, 169-52;
TWR MN 4HH-4FH-1FM, 169-53;
TWR MN 4HH-4FH-1FM, 138940-01;
TWR MN 4HH-4HM-3FM, 169-54;
TWR MN 4HH-4HM-3FM, 138952-01;
TWR MN 4HH-5FH, 169-55;
TWR MN 4HH-5FM, 169-56;
TWR MN 4HH-5FM, 138918-01;
TWR MN 4HH-6HM-2FM, 169-57;
TWR MN 4HM-5FM, 169-59;
TWR MN 5HH-3HM-3FM, 169-60;
TWR MN 5HH-9HM, 138914-01;
TWR MN 5HH-9HM, 169-61;
TWR MN 6FH-1FM, 169-62;
TWR MN 6HH-1FH-2HM-2FM, 169-63;
TWR MN 6HH-1FH-3FM, 169-64;
TWR MN 6HH-2FH-2FM, 169-65;
TWR MN 6HH-4FH, 169-67;
TWR MN 6HH-4FH, 138957-01;
TWR MN 6HH-4FM, 169-68;
TWR MN 6HH-4FM, 138922-01;
TWR MN 6HH-4HM-2FM, 169-69;
TWR MN 6HH-8HM, 169-71;
TWR MN 6HH-8HM, 138958-01;
TWR MN 7FH, 169-72;
TWR MN 7FH, 138920-01;
TWR MN 7FM, 169-73;
TWR MN 7FM, 138937-01;
TWR MN 7HH-1HM-3FM, 139086-01;
TWR MN 7HH-1HM-3FM, 169-74;
TWR MN 8HH-1FH-2FM, 169-75;
TWR MN 8HH-2FH-1FM, 169-77;
TWR MN 8HH-2HM-2FM, 169-78;
TWR MN 8HH-2HM-2FM, 138939-01;
TWR MN 8HH-3FF, 169-79;
TWR MN 8HH-3FH, 169-80;
TWR MN 8HH-3FH, 138956-01;
TWR MN 8HH-3FM, 169-81;
TWR MN 8HH-3FM, 138923-01.
BD PYXIS MEDFLEX MN (Name, REF):
1000 12HH, 139055-01;
1000 2HH-2FM, 139041-01;
1000 2HH-5FM, 139046-01;
1000 4HH-4FM, 139049-01;
1000 6HH-3FM, 139051-01;
1000 8HH-2FM, 139052-01;
2000 8HH-2FH, 139165-01;
2000 8HH-2FM, 139069-01.
MEDBANK MAIN, 1137-00;
MEDBANK MINI MAIN, 1147-00;
MEDBANK TOWER MAIN, 1145-00;
MEDFLEX, 1119-00;
MEDFLEX 2.0, 1139-00 |
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| Code Information |
REF/UDI-DI(GTIN)/Software Version:
139088-01/1.2.3.23;
169-137/10885403512544/2.4;
169-101/10885403512544/2.4;
169-102/10885403512544/2.4;
138902-01/2.4;
169-104/10885403512544/2.4;
169-105/10885403512544/2.4;
169-106/10885403512544/2.4;
138908-01/2.4;
169-107/10885403512544/2.4;
138906-01/2.4;
169-108/10885403512544/2.4;
169-110/10885403512544/2.4;
139091-01/2.4;
169-111/10885403512544/2.4;
138910-01/2.4;
169-112/10885403512544/2.4;
169-113/10885403512544/2.4;
138915-01/2.4;
169-23/10885403512568/2.4;
169-24/10885403512568/2.4;
138955-01/2.4;
169-25/10885403512568/2.4;
138924-01/2.4;
169-26/10885403512568/2.4;
138960-01/2.4;
169-27/10885403512568/2.4;
138961-01/2.4;
169-28/10885403512568/2.4;
138926-01/2.4;
138927-01/2.4;
169-29/10885403512568/2.4;
169-30/10885403512568/2.4;
169-31/10885403512568/2.4;
169-32/10885403512568/2.4;
169-33/10885403512568/2.4;
169-34/10885403512568/2.4;
169-139/10885403512568/2.4;
139125-01/2.4;
169-38/10885403512568/2.4;
138919-01/2.4;
169-39/10885403512568/2.4;
169-40/10885403512568/2.4;
169-41/10885403512568/2.4;
169-42/10885403512568/2.4;
138933-01/2.4;
169-140/10885403512568/1.2.3.23;
169-43/10885403512568/2.4;
169-44/10885403512568/2.4;
138959-01/2.4;
169-45/10885403512568/2.4;
169-46/10885403512568/2.4;
169-47/10885403512568/2.4;
169-49/10885403512568/2.4;
169-50/10885403512568/2.4;
138931-01/2.4;
169-52/10885403512568/2.4;
169-53/10885403512568/2.4;
138940-01/2.4;
169-54/10885403512568/2.4;
138952-01/2.4;
169-55/10885403512568/2.4;
169-56/10885403512568/2.4;
138918-01/2.4;
169-57/10885403512568/2.4;
169-59/10885403512568/2.4;
169-60/10885403512568/2.4;
138914-01/2.4;
169-61/10885403512568/2.4;
169-62/10885403512568/2.4;
169-63/10885403512568/2.4;
169-64/10885403512568/2.4;
169-65/10885403512568/2.4;
169-67/10885403512568/2.4;
138957-01/2.4;
169-68/10885403512568/2.4;
138922-01/2.4;
169-69/10885403512568/2.4;
169-71/10885403512568/2.4;
138958-01/2.4;
169-72/10885403512568/2.4;
138920-01/2.4;
169-73/10885403512568/2.4;
138937-01/2.4;
139086-01/2.4;
169-74/10885403512568/2.4;
169-75/10885403512568/2.4;
169-77/10885403512568/2.4;
169-78/10885403512568/2.4;
138939-01/2.4;
169-79/10885403512568/2.4;
169-80/10885403512568/2.4;
138956-01/2.4;
169-81/10885403512568/2.4;
138923-01/2.4;
139055-01/2.4;
139041-01/2.4;
139046-01/2.4;
139049-01/2.4;
139051-01/2.4;
139052-01/2.4;
139165-01/2.4;
139069-01/2.4;
1137-00/2.4;
1147-00/10885403517181/2.4;
1145-00/10885403517167/2.4;
1119-00/10885403512704/2.4;
1139-00/10885403512704/2.4
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Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
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Manufacturer Reason
for Recall | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment. |
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FDA Determined
Cause 2 | Software design |
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| Action | On 3/11/2025, 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 | 7,357 |
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| Distribution | US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR, AZ, CO, ND, GA, NE, TX, IL, OH, VT, IN, TN, KY, IA, MT, NY, CA, UT, OK, SD, WA, AK, ME, NV, NM, NC, WV, LA, MN, ID, AL, VA, WI, NH, KS, MA, CT, RI, NJ, MD, MS, WY, DC, DE, HI, AR, ON.
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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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