RecallHawk
Class II Recall

MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK

CareFusion 303, Inc.

Summary

The FDA issued a Class II for MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; ME by CareFusion 303, Inc.. Reason: If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first .

Details

Source

Device Recall

External ID

Z-1552-2025

Action Date

2025-04-23

Status

Ongoing

Category

device

Product Description

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

Lot/Code Info: 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

Quantity Affected: 2679

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-10-05

Company

CareFusion 303, Inc.

San Diego, CA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 165 device recalls issued in the same week, part of 413 device-related FDA actions this month.

CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does CareFusion 303, Inc. have FDA actions?

CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1552-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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