FDA Enforcement Class II Ongoing

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: Z-1639-2025 · Reported April 30, 2025

Enforcement

Recall Number: Z-1639-2025
Event ID: 96564
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: CareFusion 303, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: April 30, 2025
Initiation Date: March 11, 2025
Classification Date: April 18, 2025
Address: 10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

Description

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.

Code Info

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

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.

Quantity

7,357