FDA Recall: Due to a software issue, when attempting to restock the automated dispensing cabinet the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

Company: CareFusion 303, Inc.
Date of Enforcement Report: 4/9/2025
Class II

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.

Recall Number:

Z-1550-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME:

404 systems

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