FDA Recall: Software Issue During Automated Restocking May Result in Doubling Quantity Leading to Delay in Medication

Company: CareFusion 303, Inc.
Date of Enforcement Report: 04/18/2025
Class II

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

Recall Number:

Z-1639-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

CareFusion 303, Inc.

VOLUME:

7,357

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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